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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

A female patient had a cook vital-port implanted in the right brachial region for administration / transfusion of antitumor drugs on (b)(6) 2014.A chest x-ray performed as part of a routine examination on (b)(6) 2018 confirmed that the catheter broke at the connection to the port housing.The separated segment of the catheter was located inside the right atrium.The separated segment was removed with a jugular catheter inserted from the groin by a radiologist on (b)(6) 2018.There have been no additional adverse effects to the patient reported.

Manufacturer Narrative

Investigation summary: the complaint device was returned for a physical investigation.The engineering and quality engineering department performed a detailed evaluation.The catheter was returned in two pieces, one smaller fragment that remained attached to the port housing with the lock, and the other longer section of catheter.There was evidence of burnishing and bruising on the catheter surfaces near the fractured area, no calcification was present on any surface of the catheters.Both ends of the catheters at the fracture site were oval in shape which could be indicative of pinching/compression.There were puncture marks evident in the septum and it appeared that three of them suture holes were utilized.There were needled marks on the port housing.The catheter lock was received in place.There were no occlusions in the port or in the catheter when flushed.The tubing id and the outlet port od were measured and both were within specification.The instructions for use were reviewed.A potential adverse event/potential risk listed in the ifu is fracture and fragmentation, among other risks.Additionally listed in the ifu warnings: reported complications from repeated subclavian compression include catheter pinch-off syndrome, catheter fracture, and catheter shear followed by embolization of the distal portion.A review of the device history record could not be performed as the lot number was not provided.The device has been discontinued.

• 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 VASCULAR INC.; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7530649
• MDR Text Key: 108796511
• Report Number: 2522007-2018-00016
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116-N
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59