MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET AND OBTURATOR TITANIUM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number IP-S5116W

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problem Foreign body, removal of (2365)

Event Date 01/14/2015

Event Type  Injury  

Event Description

During a mini port placement in the arm of a female patient, the catheter migrated after a proximal rupture of the catheter (10 cm after the connection with the reservoir).As a result, the catheter and mini port were removed under fluoroscopy.The mini port was implanted on (b)(6) 2013 and removed on (b)(6) 2014.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET AND OBTURATOR TITANIUM
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC; vandergrift PA 15690
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4585216
• MDR Text Key: 19304561
• Report Number: 2522007-2015-00002
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: IP-S5116W
• Device Lot Number: N112579
• Other Device ID Number: UDI#:(01)00827002264724(17)160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2015
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention