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

Catalog Number IP-S5116-N

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Surgical procedure, additional (2564)

Event Date 02/18/2015

Event Type  Injury  

Event Description

The (b)(6) male pt with pre-existing condition of short bowel syndrome had the vital port implanted in 2012.The first event occurred and was reported; (1820334-2015-00103 septum leakage due to septum deterioration) on (b)(6) 2015.The second event (1820334-2015-00153) occurred to the replacement device.On (b)(6) 2015 the complaint device was placed at right femoral area.About one week after the placement of the complaint device, the user confirmed that the subdermic leakage of the medical solution (1820334-2015-00103).On (b)(6)2015 the complaint catheter was detached from the port and migrated to the right artium which confirmed by xray.On a same day, the detached catheter was removed from the right atrium by percutaneous catheter ( 1820334-2015-00153).On (b)(6) 2015 new device (ip-s5118-n) was implanted into left femoral area, then complaint port was removed from right femoral area.

Manufacturer Narrative

(b)(4).A review of complaint history 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 length of catheter (~44 cm).A visual inspection was performed under magnification, which determined that the suture holes had been used.No anomalies, burrs, or nicks were observed on the port body or its outlet tube.The catheter was inspected for signs of bruising; none were found.A dimensional verification was performed on the catheter and outlet tube, which confirmed that each was mfg to spec.A functional test was performed in which the catheter and catheter lock were assembled to the vital port body.Each fit snugly, and the components did not appear to be too loose or too tight.The device's lot number was not returned, so mfg records could not be reviewed.No evidence of mfg nonconformity was found.Due to the lack of bruising observed at the ends of the catheter, it appears that this catheter was not properly advanced over the outlet tube of the vital port.Per the complaint report, the device was implanted for less than a month.There are no signs of chronic wear on the catheter.The customer is encouraged to review the catheter connection instructions within the ifu to ensure a secure connection.

• 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.; vandergrift PA 15690
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4629646
• MDR Text Key: 5616698
• Report Number: 1820334-2015-00153
• 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: 02/19/2015

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
• Other Device ID Number: SEE FIELD H10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/20/2015
• 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: 45 YR