MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO VORTEX PORT; SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY

Model Number CT80LPPDVI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, the customer supplied a picture of the port in the patient, which appears to be protruding through the patient's skin.The picture of port implanted in patient looks to be placed shallow and/or patient lost weight after placement procedure.A picture of the catheter distal tip was provided and it confirms an occlusion at the tip, likely a fibrin sheath formation.This is common for an implantable catheter, even with the in situ time of 3.5 months.The customer's reported complaint description of difficult to aspirate and patient issue with port was confirmed via pictures provided, however, port/catheter device was not returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential root cause for port issue is being placed too shallow in patient's tissue.The aspiration difficulty was determined to be an occlusion at the catheter tip, which is likely a fibrin sheath formation that is common to implantable catheters.Device history record review of the packaging and port assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The catheter and lock are provided as a separate component within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with lock) during the implantation procedure.Labeling review: the directions for use (dfu) that is provided in the reported kit contains the following directions and precautions: contraindications: · catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Warnings: · do not use syringes smaller than 10 ml syringe when accessing the port as system damage can occur.Flushing occluded catheters with small syringes can create excessive pressures within the port system.· do not forcefully flush the port system with any syringe size.After confirmation of patency by detecting no resistance and the presence of a blood return, use syringes appropriately sized for the medication being injected.Do not transfer the medication to a larger syringe.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.· do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.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.· do not attempt to measure the patient's blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.· if the patient complains of pain, or 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.Precautions: to avert device damage and/or patient injury during catheter placement: · avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.· use only smooth-edged atraumatic clamps or forceps.· do not use the catheter if there is any evidence of mechanical damage or leaking.· avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.· carefully follow the catheter to port connection technique provided in the dfu to ensure proper device connection and to avoid catheter damage.· assure tight connection between port body and catheter.· after implantation or any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol.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).

Event Description

The treating physician reported they had a patient harmed by a port from a an 8f low profile plastic vortex port detached poly catheter filled sh valved introducer kit.After only 3.5 months of placement, the port was difficult to aspirate and eroded through the patient's skin.This issue resulted in the port needing to be removed.The pocket was packed (ongoing), leaving it open to heal by secondary intention.Blood cultures were needed due to risk of potentially lethal infection due to open wound in immunocompromised oncology patient, and resulting in delay of chemotherapy for metastatic disease (chemotherapy was suspended).Upon explantation, after only a 3.5 month dwell time, there was very aggressive ingrowth of fibrinous material into the port catheter tip lumen itself.

Event Description

Additional information received reported the port had been placed subcutaneously.The patient had not experienced any significant weight loss between the time of placement and time of the reported event.The patient has not performed any unusual activities other than normal daily living activities.

Manufacturer Narrative

Additional patient information was received.This information does not impact the investigation results provided in the initial report submitted on june 29, 2022.Reference (b)(4).

Manufacturer Narrative

Additional information was received.This information does not impact the investigation results provided in the initial report submitted on june 29, 2022 reference (b)(4).

Event Description

Additional information received reported: indication for port was for chemotherapy for colon cancer treatment with the regimen folfiri (5-fu, leucovorin, and irinotecan) patient weight close to time of implant wt 65.4 kg, ht 68cm, bmi 21.93, albumin 4.3; weight around time of explant was 62kg, albumin 4.3.Erosion at the port body site was noted on (b)(6) 2022.Port was removed on (b)(6) 2022 and the pocked allowed to heal by secondary intention.Bacterial cultures were not performed from the explant site.On (b)(6) 2022, the site was deemed healed.

Manufacturer Narrative

Additional information was received.This information does not impact the investigation results provided in the initial report submitted on june 29, 2022.Reference (b)(4).

• Brand Name: BIOFLO VORTEX PORT
• Type of Device: SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY
• 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: 14852091
• MDR Text Key: 302001900
• Report Number: 1317056-2022-00086
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPPDVI0
• UDI-Public: H787CT80LPPDVI0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT80LPPDVI
• Device Catalogue Number: CT80LPPDVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 62 KG