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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/15/2015

Event Type  Injury  

Event Description

A vital port was implanted in a female patient.On (b)(6) 2015, the port was leaking at the silicone septum.The port was removed and replaced.A section of the device did not remain inside the patients body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history was conducted for the purpose of this investigation.Because the device was not returned, no photos were provided, and the device's lot number was not given, the root cause of the complaint is unknown.There is no evidence this occurred due to manufacturing nonconformity.Per the ifu, the mini port is qualified for 400 and 1000 punctures using a 20 and 22 gauge non-coring needle.It is unclear if the total number of punctures or the nature of the punctures exceeds the tested conditions.There is no evidence that tissue trauma was caused as a result of this event.We will continue to monitor for similar events.

Event Description

A vital port was implanted in a female patient.On (b)(6) 2015, the port was leaking at the silicone septum.The port was removed and replaced.A section of the device did not remain inside the patient's body.According to the initial reporter,the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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 INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4845050
• MDR Text Key: 5912971
• Report Number: 1820334-2015-00360
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

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 Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Other Device ID Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2009
• 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