MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT & CATHETER

Model Number CT66LTPD

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problem Infiltration into Tissue (1931)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient was at end of therapy when they identified the line was blocked.When removing the device, the surgeon reportedly observed a "tissue reaction" on the patient.The "line" (catheter) was mentioned to be "blocked" and hence the decision for the removal of the port was made.The doctor made a primary incision for the removal/explant of the port.It was reported that when the pocket was opened, the catheter would not pull out of the tunnel.Therefore, "many more" than usual additional incisions were required on the neck to approach the catheter from another angle in order to successfully remove the device.Details of the removal procedure are as follows: elective admission for removal of right internal jugular vein port as end of therapy.Incision through previous scar adjacent to port.Dissection and mobilisation of port using diathermy, and removal of prolene stay suture.Traction to catheter to attempt to remove, but significant resistance encountered, and tethering of catheter noted to subcutaneous tissues along the tract of the catheter.Dissection around catheter attempted, but catheter still fixed within subcutaneous tissues, and at neck.Previous neck incision opened, further dissection at this site to mobilise catheter allowed the catheter to then be retrieved from the internal jugular vein, but catheter still required significant dissection along subcutaneous tract in order to mobilise, and with persistent tethering still noted further along the subcutaneous tract, a 3rd incision then required along the chest wall (approximately mid-way between neck incision and port site incision) in order to mobilise the catheter/dissect it free from subcutaneous tissues.Hence why catheter was then cut into pieces as part of the removal process.Of note the catheter appeared "rough" and appeared to have fibrous ingrowth along its length, which is not what the provider usually encounters with port catheter removals, as usually the catheter slides freely out from a fibrous sheet and appears clean/white after its removal.The line did not snap, but it would have snapped or broken if more traction was applied to remove it.The line did not just "slide out" from the tissues as they usually would, and there was clearly ingrowth of fibrous tissue along the length of the catheter and not just at the insertion site into the vein or at the suture site of the port.The line is in pieces however because the provider had to cut it and remove it from the patient via 3 separate incisions with dissection along the catheter through each of these separate incisions in order to mobilise it free from her tissues.There were actually 2 additional incisions (and 3 incisions in total) to remove this device (whereas usually only 1 incision - over the port is required).For this patient, in addition to the incision over the port, she did require the neck incision, and additionally a 3rd incision over the chest wall (at a point approximately midway between the neck and port site incisions, in order to further dissect/mobilise the catheter free from the subcutaneous tissues.Without this 3rd incision the catheter would have snapped or broken and would not have been totally removed from the patient.The only complication was the requirement of an additional (3rd) skin incision in order to remove the device.And a slightly longer anaesthetic than would usually be required for a port removal (anaesthetic time was approximately 1 hour 30mins).

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was one (1) smartport.As received, approximately 7cm of catheter tubing was attached to the port.The customer returned approximately 13cm of catheter tubing.  the catheter tubing attached to the port also contained a kink at the 3cm mark.The port and catheter tubing were occluded with bio material {blood}.The customer's reported complaint description of port catheter tubing occluded was confirmed based on evaluation of the returned port and catheter tubing as received; lumen occluded with dried blood, but this is expected for a returned used device.The reported complaint of catheter difficult to remove was confirmed as the exterior of the catheter tubing (portion near port device that would be in tunneled area) had a rough surface indicating it was adhered to tissue.Although the reported complaint description is confirmed, a definitive root cause cannot be determined.The returned catheter was observed to have rough surface on the exterior of the catheter near the port housing and tunneled area. this most likely contributed to the difficult to remove catheter event experienced during the port explant procedure.However, we are unable to determine an exact root cause for the rough exterior surface.  no manufacturing related non-conformances were observed during evaluation of the returned port/catheter tubing.   a review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use, which is supplied to the user with this catalog number, contains the following statements: absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.A blood return should be present prior to usage of device for any therapy or testing.If the patient complains of pain, or if there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Caution: avoid piercing catheter with suture needle.Potential complications: catheter fragmentation and catheter pinch-off.Catheter placement considerations: warning: avoid medial catheter placement into sub-clavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SMART PORT
• Type of Device: PORT & CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15561367
• MDR Text Key: 307024269
• Report Number: 1317056-2022-00122
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: CT66LTPD
• Device Catalogue Number: CT66LTPD
• Device Lot Number: 5397469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female