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

Catalog Number IP-S5116-N

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Investigation summary: the complaint device was not returned, therefore a physical examination could not be performed and no photographs were provided.The complaint could only be confirmed through customer testimony.This is a known failure mode of this device and a risk assessment will be completed per quality engineering risk assessment (qera).The device history record was reviewed and there are no signs in the device history record to indicate that this vital port was shipped to the field nonconforming.The root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Event Description

From the complaint description, the port catheter detached from the port housing and had to be retrieved from an undisclosed part of the vascular system.

• 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
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 7464430
• MDR Text Key: 106610071
• Report Number: 2522007-2017-00053
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00827002465466
• UDI-Public: (01)00827002465466(17)190930(10)N141343
• Combination Product (y/n): N
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IP-S5116-N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2017
• Date Device Manufactured: 10/25/2016
• 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): Required Intervention