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

Catalog Number IP-5116-N

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Foreign body, removal of (2365)

Event Date 12/24/2014

Event Type  Injury  

Event Description

A (b)(6) female pt has a ivc port placement performed for chemotherapy.The device was placed in the left upper arm on (b)(6) 2014.The first chemotherapy was planned on (b)(6) 2014, however the physician confirmed that the catheter was separated from the port outlet and the detached catheter migrated to the left pulmonary artery.On the same day at 6:30 pm, the cardiologist removed the detached catheter by percutaneous catheter, and the port was removed from left upper arm.The locking sleeve was disconnected.No adverse effects occurred due to detachment and migration of the catheter.The chemotherapy was performed from peripheral vein.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• 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: 4452615
• MDR Text Key: 5424391
• Report Number: 2522007-2015-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/25/2014

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: 12/31/2016
• Device Catalogue Number: IP-5116-N
• Device Lot Number: N117582
• Other Device ID Number: (01)00827002465442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2014
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/26/2014
• Initial Date FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 46