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 03/02/2018

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

The vital-port vascular access system was implanted on (b)(6) 2017.A mid-catheter leak was detected on (b)(6) 2018.The catheter detached completely and had to be removed from pulmonary artery on (b)(6) 2018.

Manufacturer Narrative

Investigation summary: the complaint device was not returned for a physical examination.The quality engineering department could not perform a physical investigation.Without a physical investigation of the device, a defect or malfunction of the device or manufacturing process is inconclusive.The instructions for use was reviewed and listed as potential adverse events is 'catheter disconnection, fracture and fragmentation.' catheter disconnect/detachment is a known failure mode of the vital port, and is being tracked and trended.This device has been discontinued.The device history record for this lot number was completed, including the manufacturing and quality control activities.All process steps were complete and signed off by trained personnel.There are no signs in the device history record to indicate that this vital port was shipped to the field nonconforming.

• 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: 7517898
• MDR Text Key: 108492224
• Report Number: 2522007-2018-00015
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)200831(10)N149167
• 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: 05/16/2018
• 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-S5116W-MPIS-NT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention