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

Catalog Number IP-S5116W-MPIS-NT

Device Problem Material Erosion (1214)

Patient Problem Foreign body, removal of (2365)

Event Type  Injury  

Event Description

The port has eroded through the skin due to infection.The port was explanted due to skin erosion.

Manufacturer Narrative

(b)(4).According to the information provided, the device will not be returned for evaluation.The customer complaint indicates that a patient with this device developed an infection during the procedure.The duration of implantation is unknown, as is the device's lot number.Sterilization records from the past 2 years show no indication that validated parameters were not met for runs used to sterilize the product.There is no evidence that a nonconformity occurred during manufacturing or sterilization processing.There is no evidence to suggest the product was not manufactured to specification.Due to the device not being returned and the lot number being unavailable, the device could not be inspected and the specific sterilization run could not be reviewed for nonconformity.Based on a review of other sterilization runs, there is no evidence that an error occurred during sterilization that would cause this complaint.The root cause is unknown.No further action will be taken.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: 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: 4685517
• MDR Text Key: 5642995
• Report Number: 1820334-2015-00213
• 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,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/18/2015

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-S5116W-MPIS-NT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other