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 Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 01/28/2015

Event Type  Injury  

Event Description

The complaint device was implanted in a (b)(6) male patients' femoral area in 2012 (exact date unknown).On (b)(6) 2015, during a cv port placement, when the physician flushed the drug solution, he confirmed there was drug leakage from the septum, and along the injected needle.The physician did notice that when he flushed slowly, he could not see the leakage; however it occurred with pressure.On (b)(6) 2015, a replacement of the cv port was performed.No information was provided regarding patient outcome.

Manufacturer Narrative

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

• 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.; vandergrift PA 15690
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4564842
• MDR Text Key: 5550735
• Report Number: 1820334-2015-00103
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2015

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 Catalogue Number: IP-S5116-N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 45 YR