MAUDE Adverse Event Report: COOK VASCULAR 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 Problem Swelling (2091)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

Lot # requested but not provided.(b)(4).The event is currently under investigation.

Event Description

The device was placed in the subclavian area of the patient on (b)(6) 2015.On (b)(6) 2015, while injection of the anticancer medicine (attempting of 6th bottle), uncomfortable feeling on the site where the vital port was placed was confirmed.At 10:35pm, it was confirmed the swelling on the patient where the vital port was around the insertion area.The vital port was removed from the patient on (b)(6) 2015.

Manufacturer Narrative

(b)(4).**** event evaluation **** a review of complaint history was conducted during the investigation.One used ip-s5116-n mini titanium vital port was returned with this complaint along with an assembled catheter lock and length of catheter.The catheter and catheter lock were assembled per the guidance in the ifu.The device and its components were observed under magnification, and no nicks, cuts, or anomalies were observed on the catheter or port body.No signs of wear or fracture were present on the catheter, which was cut squarely at both ends.The suture holes show no signs of use.A dimensional verification was performed on the catheter and the port body's outlet tube and all dimensions meet the acceptance criteria.The device was able to be flushed prior to decontamination.No obstructions were expelled from the catheter during this test.A leak check was performed in which the catheter and lock were assembled to the returned vital port body and the distal end of the catheter was assembled to a second mini titanium vital port body.The device was then flushed with a syringe filled with water.No leaks were observed on the catheter, underneath the lock, or on the vital port body.No components failed during this test.Because the device's lot number was not provided, manufacturing records cannot be reviewed.No signs of device nonconformity were found during the investigation.

Event Description

The device was placed in the subclavian area of the patient on (b)(6) 2015.On (b)(6) 2015, while injection of the anticancer medicine (attempting of 6th bottle), uncomfortable feeling on the site where the vital port was placed was confirmed.At 10:35pm, it was confirmed the swelling on the patient where the vital port was around the insertion area.The vital port was removed from the patient on (b)(6) 2015.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5419996
• MDR Text Key: 37796095
• Report Number: 1820334-2016-00070
• Device Sequence Number: 1
• Product Code: DWF
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

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-S5116-N
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 80 YR