Summary of MedSun Reports Describing Problems With Implanted Subcutaneous Ports and Catheters
MedSun: Newsletter #64, September 2011

Implanted subcutaneous ports and catheters consist of an implanted reservoir that connects to a long-term intravascular catheter which allows for repeated access to the vascular system for infusion of fluids, medications, and sampling of blood. Specially designed ports may also be used for power injection of contrast media. The portal body with a resealable septum and outlet is made of metal, plastic, or a combination of these materials. The catheter is either pre-attached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design (Code of Federal Regulation, Title 21). Over the past year MedSun has received 51 adverse event reports associated with implanted port devices manufactured by the following firms: AngioDynamics, Bard Access Systems, Inc., MedComp, Navilyst Medical, and Smiths Medical. The reports were submitted by 33 hospitals between June 2010 and June 2011.

The reported device problems were:
• 13 reports associated with breaks
• 18 reports associated with cracks, splits, and fractures
• 6 reports associated with device separation
• 3 reports associated with retained foreign body
• 3 reports associated with hole/torn material
• 3 reports associated with leaks
• 2 reports associated with failure to aspirate/inoperable
• 1 report associated with a wrinkled sheath
• 1 report associated with the device expiration
• 1 report associated with migration

There were no reports that resulted in patient death and 36 reports had no patient problems reported. In the reports where a patient problem was identified, one or more problems may have occurred. In 15 reports the patient problems reported were:
• 5 reports of pain
• 3 reports of extravasation
• 2 reports of erythema
• 2 reports of device fragments in patient
• 2 reports of swelling, and bruising
• 1 report of infection
• 1 report of embolism
• 1 report of a needle stick

Of the reports that listed patient age, 6 had a patient age listed as less than 21 years and 37 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 20 reports involved female patients and a total of 17 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with implanted ports since June 2010 through June 2011. The MedSun Reported events may, or may not, be involved in the recall(s) listed.

Recall Number: Z-2671-2011
Date Posted: June 27, 2011
Product: B. Braun Celsite Venous Access Port
Code Information: Reference # Model# Lot# 04430425 ST301 J31396U 04430095 ST305V J312177U 04433823 ST301G J313197U K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U
Recalling Firm/Manufacturer: B. Braun Interventional Systems
Action: B. Braun Interventional Systems, Inc. sent an Urgent Medical Device Recall letter on April 16, 2011 to all affected customers.
Distribution: NY, ND, OK, PA
Link: http://www.accessdata.fda.gov/scripts/cdrh/cjdosc/cfRES/res.cfm?id=100140

Recall Number: Z-2235-2010
Date Posted: August 17, 2010
Product: MedComp ® Low Profile CT Port with Pre-Attached Chronoflex ® Polyurethane Catheter
Code Information: Lot# MAZL603, Exp. 04/2015
Recalling Firm/Manufacturer: Medical Components, Inc.
Action: Medcomp sales reps and foreign distributor were notified via email on 7/1/2010. Product is to be returned to Medcomp.
Distribution: Worldwide and country of Israel.
Link: http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=93071

Recall Number: Z-1874-2010
Date Posted: July 1, 2010
Product: Navilyst Medical, Inc. Vaxcel ™ Port Titanium Standard Port with 8F Silicone Catheter
Code Information: Catalog no. 45-320, UPN# M001453200, Sterile, Rx only. Previously distributed by Boston Scientific Corporation. Lots 1264960, 1283256, 1342235, 1371638
Recalling Firm/Manufacturer: Navilyst Medical, Inc.
Action: Navilyst sent Urgent Medical Device Recall-Immediate Action Required letter/recall notification packages on May 12, 2010
Distribution: Worldwide and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=91839


The following table lists the MedSun reports that are described in the device problem summary above.

Additional Information:

CFR - Code of Federal Regulations Title 21. Online available:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5965


MedSun Newsletters are available at www.fda.gov/cdrh/medsun
MedSun Reports Describing Problems with Implanted Subcutaneous Ports and Catheters
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
AngioDynamics Catalog# CT96STSD During the placement of the AngioDynamics Vortex Smart Port(ref CT96STSD), the blue protective cover of the metal tunneling device was not removed, but inadvertently left on the tunneling device during the tunneling. It moved down the tunneling device and was left over the catheter in the subcutaneous tissue. The blue cover was not visualized on fluoro or x-ray. The port and catheter was removed ten months later because the patient did not need the port any longer. However, the blue cover was not visualized and was not removed. Approximately two weeks later the patient returned for removal of a retained foreign body. Device problem that contributed to the user error: 1.The blue tunneling cover is the same color as the blue locking mechanism 2. The blue tunneling cover is not marked with a radiopaque marker 3. The blue tunneling cover can slide down the tunneling device. It is not a luer or twist off cap.
AngioDynamics/Smart Port Ct Catalog# CT66LTPD Lot# 534770 Smart Port was being prepared to be implanted in patient. It was flushed with heparin and the tubing was seen to be leaking. A second port was opened and utilized to complete the procedure.
Medcomp Catalog# MRCT166041M Lot# MBDJ570 Staff believe the peel away sheath was defective. It wrinkled and would not insert. A second catheter was used with no trouble.
Bard Access Systems, Inc./PowerPort Model# 1808060 Lot# RESE0776 Patient came in for port catheter removal. MD removed right internal jugular PowerPort. Patient later identified lump under skin; ultrasound revealed a small piece of plastic from the PowerPort retained after port catheter removal.
Bard Access Systems, Inc./PowerPort Model# 1808000 Lot# REUA0625 Patient has stage III ovarian cancer. PowerPort implanted for administration of chemotherapeutic medication. During CT scan, a hole was discovered in the catheter when contrast was being pushed.
Bard Access Systems Inc./MRI Low-Profile Implanted Port Catalog# 6603880 Port implanted four years ago. Two months ago the patient returned to the Emergency Department with complaints of pain under left breast. The CT angiogram showed the catheter had fractured just distal to the catheter hub. The port and catheter were successfully removed.
Bard Access Systems Inc./MRI Low-Profile Implanted Port Lot# REUD1022 Patient presents to facility with non-functioning port. The port was accessed and would not flush or aspirate. The port was believed to be occluded. The patient was brought to the OR for a revision. The port was accessed and contrast was injected. Extravasation contrast was noted at the port hub connection. The port was removed.
Bard Access Systems, Inc./Groshong Catheter with PowerPort Catalog# 1808560 Patient with recurrent leiomyosarcoma of uterus had Groshong catheter PowerPort placed in the left subclavian. The device was removed a month later. During removal the catheter broke off device, which then required removal by Interventional Radiology. The port catheter fractured at the base where it attaches to the port. This was discovered when saline was ran through the port.
Bard Access Systems, Inc./PowerPort Unknown Port catheter was noted to have a 6-mm vertical split in subclavian region upon scheduled removal.
Bard Access Systems, Inc./X-Port ISP Catalog# 0607555 Lot# REUI1270 The guide wire was threaded through the needle that was inserted into the internal jugular vein. The skin was incised in preparation for insertion of the port. The silicone catheter was tunneled under the skin using the tunneling device. The dilator was threaded over the guide wire. The guide wire was removed through the patent dilator. At the completion of the procedure, the surgeon noted that the guide wire core was broken and the outer wire surrounding the core appeared to be unraveled.
Navilyst Medical/Xcela Power Injectable Port Catalog# H965451030 RN in ER accessed patient's port with a power loc safety needle because he had a port catheter device card that indicated the port was an Xcela Power Injectable Port suitable for IV contrast injection. RN used this card as identifier, but when patient went to CT x-ray of chest was done as second identifier and the "CT" symbol that was supposed to be second ID was not on the port. This made the port unusable per our policy and since patient refused to have IV started for contrast CT had to be done w/o contrast. Product is supposed to have this symbol on their ports suitable for use with IV contrast and with the power loc needle.
MedComp Catalog# MR594048P Lot#MAWN690 Patient had a low profile 4.8 Fr. indwelling medication port. A bubbly blood return was detected during a port check. The port was flushed and the dressing became wet. Intraoperatively, the patient was noted to have a hole through the back wall of the port. The port was explanted and replaced with a new port. The explanted port had two needle punctures through the plastic needle stop backing.
Bard Access System, Inc. Model# 605420 Malfunctioning port was removed. According to the surgeon, it was leaking. Notes from the history and physical: “Recently she developed some symptoms including pain and swelling with access and injection of the port. A portogram demonstrated a leak in the proximal portion of the catheter and she now presents for removal of that catheter." Notes from the operative report. "The port was examined. I did not see any obvious crack or erosions in the catheter." There were no complications. The patient tolerated the procedure well.
Bard Access System Model# 607540 Lot# REUA1232 An 8 French catheter was being inserted in preparation for chemotherapy. The introducer to the catheter broke while being inserted. The patient was not injured.
Bard Acesss Systems Catalog# 1808560 Lot# RETJ0442 Bard Groshong Catheter with Power Port implanted. Fifteen months later patient having port flushed when physician noticed approximately 20 cm of distal tip of guide wire sticking out of the catheter.
Bard Access Systems Model# 9954 Bard Mediport part catheter tip broke off into two pieces inside patient and the tip traveled to the left ventricle. Pieces of the catheter and port were successfully removed. Mediport and two pieces of catheter were saved and returned to patient after taking pictures.
AngioDynamics/Vortex TR Vascular Access Port Model# SSAX-16-1 Five months ago a port was removed from a patient who had completed cancer treatment. Unbeknownst to the surgeon at the time, the strain relief sleeve was retained subcutaneously in the soft tissue of the patient's left upper chest wall. The strain relief sleeve is a piece of silicone tubing about 2cm long that fits over the connection of the port reservoir stem and the catheter. No record could be located for the port lot number. However, at the time the operating room was using the above model for that size port exclusively in patients on the pediatric service. Recently the surgery team was first made aware that the patient was complaining of discomfort from an object under the skin medial and adjacent to the port incision scar. The shape of the object matches the size of the catheter sleeve seen on the chest x-ray.
Bard Access Systems, Inc./PowerPort Groshong Lot# RETK005 Patient had a malfunctioning port. He receives chemotherapy. Patient was taken to the OR and a break in the catheter was found. Catheter was replaced and is functioning.
Bard Access Systems, Inc./PowerPort* isp M.R.I.* Implantable Port Catalog# 1808560 Port catheter was inserted. A piece of the port sheared off and ended up in pt's right ventricle. The doctor removed the port and catheter immediately. The field rep retrieved the defective port/catheter and reported to FDA. Patient had a port reinserted on the other side.
Bard Access Systems, Inc. Catalog# 0602240 Lot# RETH0831 Patient had port catheter removed due to positive blood cultures and a tender incision site. The wound was angry and pus filled. The physician was trying to manipulate the port as little as possible during the removal dissection process. The patient learned a year later there was a small retained piece in the soft tissue of the pectoralis muscle. There are 3 pieces to the port catheter. The tubing, the hub mechanism, and the port itself. It was the hub mechanism that was retained. It was superficial and safely removed. The hub mechanism is not radiopaque.
Bard Access Systems, Inc./PowerPort Catalog# 1808060 Lot# RETK0668 The port catheter used for chemotherapy was scheduled to be removed. Upon removal it was noted that a crack was in catheter.
AngioDynamics/SmartPort CT Catalog# CT80STPD Lot# 503654 Port catheter was removed from patient. Catheter was non-functioning and had a fracture in the tubing.
AngioDynamics/SmartPort CT Catalog# CT80STPD Lot# 995830 Port catheter was removed from patient. Catheter was non-functioning and had a fracture in the tubing.
Smith Medical MD, Inc./Gripper Plus Power p.a.c. Model# 21-3362 Lot#470x38 While deaccessing a patient's port catheter, the device was very difficult to remove and required pulling more firmly. It finally came out, but did not retract into the foam covering resulting in a needle slice to the nurse's left thumb.
Bard Access Systems Inc./PowerPort Catalog# 1808000 Lot# RES80919 Upon removal of PowerPort, the catheter was noted to be split.
Smiths Medical MD Inc. Model# 21-4483 Lot# 1807288 Physician was implanting a Deltec single lumen PowerPort in patient. When advancing the catheter onto the port hub the catheter tore off with a portion of the catheter remaining on the port. A new port was needed and the catheter was trimmed to fit on the new port. The same catheter remained.
Bard Access Systems Inc./PowerPort Catalog# 1808000 Lot# RETE0243 PowerPort was removed. It was noted that a crack was in the catheter.
Angiodynamics/SmartPort CT with Vortex Port Catalog# CT96STSD Lot#519430 Patient had port catheter placed in left subclavian and returned seven months later with suspicion of access line fracture of the catheter. The catheter was evaluated and during this process ruptured into the proximal portion. The fractured port catheter was successfully removed. There was no patient injury.
Angiodynamics/Vortex SmartPort Catalog# CT965TSD Lot# 994828 Patient had port catheter placed in left subclavian. The patient returned nine months later for a non-functioning catheter. Chest x-ray revealed a fracture of the catheter between the first rib and the clavicle with tip in the right atrium. The catheter was successfully removed the following day. There was no patient injury.
Angiodynamics/CT SmartPort Catalog# CT96STSD Patient had a port catheter placed in left subclavian at this facility and returned seventeen months later due to a non-functioning catheter. A portogram showed a fractured catheter at the junction of the first rib and clavicle. The distal tip was in proper position and the catheter was tested. However, the surgeon was unable to demonstrate any type of leak from the catheter. The catheter was removed successfully the following month and a new one was placed in the right subclavian. The removed catheter was sent to pathology for evaluation. There was no patient injury.
Angiodynamics/CT SmartPort Catalog# CT96STSD Lot# 995828 Patient had port catheter placed at this facility and returned six months later due to non-functioning catheter. Upon removal, it was noted the port tubing had broken completely apart and the detached portion had migrated to the patient's heart. The remaining portion of the tubing was removed successfully in tact. There was no patient injury.
Bard Access Systems Inc. Model# 602660 Lot# REUD0913 During general surgery a split sheath broke at the handle externally to the percutaneous site.
AngioDynamics/Vortex VX Vascular Access Port Lot# 25384 The low profile AngioDynamics catheter stopped working. The surgeon decided to remove the catheter and discovered that it was broken during the explantation process.
AngioDynamics Catalog# MP-P5SAT Lot# 503882 Patient scheduled to have a mediport dye study for assessment of mediport. This study was being completed due to the fact that the parents, homecare, and outside hospital were not having success with blood returns even with interventions such as altepase. After mediport accessed and an image was taken, it was noted by MD that the catheter was detached from the mediport. The tubing and port were removed and was replaced with new line.
Bard Access Systems, Inc./Port Low Profile Catalog# 605840 Lot# REUA0729 During chemotherapy treatment it was noted the staff had some difficulty accessing her port. The patient states that the same evening she had pain around the port in her left chest. The patient noted some redness and slight swelling. The patient apparently had a problem with extravasation of some of the chemotherapeutic agents in the subcutaneous space around her left subclavian port hub site. There is an impression from the surgeon that a linear tear of about .5 cm was apparent in the catheter.
Bard Access Systems, Inc./PowerPort Duo Lumen Model# 1829500 The port was removed about thirteen weeks later due to non-functioning.
Boston Scientific Lot# 1123660 Patient had this Infusaport implanted four years ago for chemotherapy administration. A few weeks ago, after having determined that the port was dysfunctional, this patient went to surgery to have the port removed. The surgeon placed the catheter in traction and immediately noted that the catheter separated from the port apparatus with minimal pressure. It sheared off at the hub. This was a clean cut. The patient did not suffer an adverse event. However, the surgeon believed this port had fatigued, which probably caused this event.
Bard Access Systems, Inc./PowerPort Catalog# 1808060 Lot# RETK0974 Port had been implanted earlier this year. The catheter was split rendering it unusable. Six months later the device was removed and replaced.
Bard Access Systems, Inc./ PowerPort Unknown The PowerPort catheter was removed after it was found to have two splits in catheter. The device was replaced with new PowerPort.
Bard Access Systems, Inc./PowerPort Unknown The PowerPort catheter was due for removal, as patient had completed chemotherapy. Upon removal of catheter, surgeon noted that the catheter was split.
Bard Access Systems, Inc./MRI Low Profile Implanted Port Catalog# 0603880 Lot# REUF0110 Surgeon reports that the outer sheath is almost impossible to split and remove.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 949904 Catheter broke into multiple pieces upon removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 29209 Catheter broke into multiple pieces upon removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 26330 Catheter broke into multiple pieces during removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 947059 The locking collar separated from the main body of the Vortex port, and the port catheter fractured at the tip of the spigot. A second incision was made superior to the port pocket and the catheter shaft was exposed. The catheter shaft was encircled with loops. The shaft was severed and a microwire was passed through the residual catheter fragment into the venous system and manipulated down into the inferior vena cava. The port collar and small fractured catheter fragment were then dissected free from the site of the port pocket. Next came the removal of the internal port catheter fracture, which required blunt and sharp dissection around the subcutaneous tunnel all the way up to the root of the neck where the catheter entered the internal jugular vein. This was performed from the secondary incision circumferentially around the catheter. Thus, the remaining catheter fragment was explanted intact.
Bard Access Systems, Inc./PowerPort Catalog# 1809600 Lot# REUDO409 After the port was inserted the nurse was not able to aspirate blood. However, the port flushed with ease. 500ml of saline was infused and a cardiac drug was given. After infusing a portion of a unit of blood, the patient had swelling surrounding the port site. The transfusion was discontinued at that site and a peripheral IV was started.
Smiths Medical/Port-A-Cath II Model# 21-4055 Lot#M39098 Patient had a port catheter placed five years ago for monthly IVIG (intravenous gamma globulin injections). The day before admission, the IVIG was attempted to be placed in the port-a-catheter, but there was extravasation confirmed by a dye study. The patient developed pain at the site and faint erythema over the breast. She was taken to the operating room where the port itself came out. There was a split in the catheter right at the port insertion site, which explained the extravasation. The catheter absolutely would not leave the tract. It was dissected down to where the catheter dived underneath the first rib, clavicle, and sternum, but would not dislodge. After intraoperative phone conversation with a chest surgeon, a decision was made that the most prudent thing was to just ligate the catheter, cut it, and leave it in the end of the subcutaneous space. Although this is not ideal, it seemed more appropriate than actually going into her chest after the catheter. The patient received intravenous antibiotics overnight, and the following morning the slight erythema over her chest was improving. There was slight bruising at the site of removal, otherwise it looked benign. She was therefore discharged to home with another six days of oral antibiotics. Plans are to have a new port placed once she has been without any evidence of infection for approximately a week.
Bard Access Systems, Inc. Model#1806061 Lot#RESJ007 A port was placed in the patient. After completion, it was noticed that the product had expired.
Bard Access Systems, Inc. Model# 602270 Lot# REUC1573 The physician was inserting an implantable port. After the port was secured in place, the physician attempted to remove the introducer. There are two tabs on either side of the introducer that are used to do this. As the tabs were pulled, one of them broke off in the surgeon's hand. The surgeon was able to remove the introducer without incident. The patient was not harmed. However, the surgeon said he considers this to be very dangerous as the event had the potential to have ruptured the patient's artery. The surgeon and staff involved in the event are very experienced and have performed this procedure hundreds of times. No one involved in the event, including the physician, has had this happen before. There were no obvious defects to the device that were seen before implanting the port. No unusual/excessive force was used to pull the tabs. The tabs were not twisted, flexed, or dorsiflexed. The surgeon believes there may be a problem with the way this device was manufactured. The port itself remains inside the patient. The introducer and tabs as well as device packaging are being returned to the manufacturer. We are awaiting their device return kit at this time. The surgeon believes there may be a problem with the way this device was manufactured.
Bard Access Systems/PowerPort Catalog# 1088061 Lot# RESE0885 The patient had surgery to remove the cracked Bard PowerPort. The PowerPort was originally inserted approximately 22 months ago by the same surgeon. The surgeon replaced with a new Bard PowerPort. The cracked explant was sent to the lab with instructions to then forward the device to Risk Management.
Navilyst Medical/VAXCEL Catalog# 46-363 Lot#1373199 During outpatient infusion of chemotherapy through a port catheter inserted approximately seven weeks ago, a leak was noticed by patient's oncologist. Patient with history of breast cancer returned to OR for ambulatory removal of the port catheter and insertion of a new port catheter. The leak was found at the base of the device.