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 Problems Break (1069); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Approximate age of device is currently unknown as lot information is currently unknown.(b)(4).Device manufacture date unknown as lot information is currently unknown.The event is currently under investigation.

Event Description

The catheter tore off and had to be secured from the lungs.The physician was not able to remove the separated portion by administering some nacl (sodium chloride).So they performed an x-ray and noted that the catheter was broken and migrated to the lung.An intervention procedure was made to retrieve the catheter and the port body out.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - a review of the complaint history and a visual inspection of the complaint device was conducted for the purpose of this investigation.Visual inspection confirmed that the catheter fractured during use.The presence of wear and burnishing at several points on the od of the catheter confirms that the fracture was due to long term wear.Because the catheter is curved at the point of fracture and the wear occurs on the inside of the curve, it appears that the device fractured at a bend within the patient's anatomy.There are no signs that the device's suture holes were used, which could contribute to forces exerted on the catheter that lead to the fracture.The reported implantation location does not correspond with that identified in the device ifu (instructions for use).Long-term repetitive movement of the patient's arm likely caused the wear on the catheter, which was exacerbated by the location of the implantation and the unsecured port body.Due to the device's lot number not being provided, manufacturing records could not be reviewed.Comments on the complaint form indicate that the device was implanted for greater than 2 years.No signs were found that indicate the wrong size or material of catheter was used.There are no signs that indicate this device was not manufactured to current specifications.We will continue to monitor for similar events.

Event Description

The catheter tore off and had to be secured from the lungs.The physician was not able to remove the separated portion by administering some nacl (sodium chloride).So they performed an x-ray and noted that the catheter was broken and migrated to the lung.An intervention procedure was made to retrieve the catheter and the port body out.A section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not 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 VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5460449
• MDR Text Key: 39036275
• Report Number: 1820334-2016-00095
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

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-S5116W-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• 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