MAUDE Adverse Event Report: COOK VANDERGRIFT INC VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number IP-S5116-N

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Swelling (2091)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacture of this device was discontinued in november 2017.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.

Event Description

It was reported that during a chemotherapy administration that subcutaneous reddening and swelling were observed around the vital-port detached silicone catheter titanium infusion port.This device had been placed in the subclavian vein 10 years ago for weekly to biweekly use.Due to the leakage, the vital-port detached silicone catheter titanium infusion port had to be surgically removed from the patient on (b)(6) 2019, and was then replaced by a different manufacturer¿s device.Although additional information regarding the device have been requested, no further information has been forth coming.

Event Description

No new event information has been received since the last report was filed.

Manufacturer Narrative

H6 - added patient code desc 2: extravasation (1842), (labeled).Investigation/evaluation: this complaint was entered into trackwise as: "leakage from the vital port".This port was implanted ten years ago, which the lot number was unknown.Three used parts of a vital port were returned.The quality engineering department performed the investigation of the vital port.The ends of the tubing, that is approximately 20.5mm long, appear to have been cut.The port has an orange peel effect.Not all of the suture points appear to have punctures.One suture point appears to have a slice in it due to a needle miss.A functional test was performed and the port housing, the tubing, and the end cap were not occluded by flushing all three parts with a syringe and needle.The top of the port has marks on the port housing that may have been caused from a needle stick misses.Due to the septum having a significant amount of needle sticks, after confirming catheter was not occluded, a reverse flush was performed on the port, which visually showed no sign of leakage on the port housing itself.Per ifu, "failure to adequately anchor the port to the fascia increases the risk of catheter fracture and/or disconnection which could result in catheter migration." and "in vitro testing has shown sealing integrity after 1200 and 2500 punctures for 20 and 22ga, respectively (400 and 1000 punctures for the mini).Septum lifetime may vary, depending on clinical use." leaking has been previously reported with the vital ports, and this failure mode will be tracked/trended and monitored per the cvi post market surveillance and complaint handling processes.Leaking has been previously reported with the vital ports, and this failure mode will be tracked/trended and monitored per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.No dhr review was conducted as the lot number is unknown.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 8786606
• MDR Text Key: 150999673
• Report Number: 2522007-2019-00005
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IP-S5116-N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention