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-5116-N

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 03/24/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, for the purpose of nutrition management, the complaint port was placed in the right anterior chest of a female pt.The catheter was inserted from right internal vein.She was under chemical treatment against recurrent ovarian cancer.She also suffered from subileus due to peritoneal dissemination.However, since the pt complained pain after the port placement, the port was not used on that day, but only heparin lock of the catheter was conducted.On (b)(6) 2015, the physician planned to start using the port on this day and therefore, checked the back flow of blood through the port first to test the patency of the catheter, which confirmed back flow.However, as subcutaneous edema occurred and the pt complained pain in the region from cervical part to chest then, use the port was canceled.On (b)(6) 2015, in order to check whether the port and the catheter were connected properly each other, the physician incised the port pocket of the anterior chest under local anesthesia, which revealed that only locking sleeve was attached to the port and the catheter had been disconnected from it.Because the catheter was found to have flown into the right atrium, it was retrieved by using ensnare.

Manufacturer Narrative

(b)(4).A review of complaint history, device history record, instructions for use (ifu), and a visual inspection and dimensional verification of the returned device were conducted during the investigation.One used mini titanium vital port was returned along with a catheter lock and a length of catheter ( approximately 19 cm).A visual inspection was performed under magnification.No signs of bruising (a sign of proper advancement) were observed on the ends of the catheter.It was confirmed that one suture hole of the device was used.Per a comment within the complaint report, this event occurred less than a month following implantation.A dimensional verification was performed on the catheter and outlet tube.All dimensions measured were within specification.Manufacturing records for this device were reviewed, and no evidence of nonconformity was found.No other complaints have been filed for devices from this manufacturing lot.There is no evidence to suggest the product was not manufactured to specification.Because no signs of bruising were observed on the ends of the catheter, it appears the catheter was not advanced over the outlet tube per the instructions and diagrams within the ifu.This supported by the duration of time between implantation and the complaint event (10 days).No evidence of manufacturing nonconformity was found during the complaint 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, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4745939
• MDR Text Key: 5709009
• Report Number: 1820334-2015-00266
• 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: 04/06/2015

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: 10/31/2016
• Device Catalogue Number: IP-5116-N
• Device Lot Number: N116889
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2015
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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