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-S5116W-MPIS-NT

Device Problem Laser tip separation (1346)

Patient Problem Foreign body, removal of (2365)

Event Date 03/14/2015

Event Type  Injury  

Event Description

The female pt came into the hospital because the port was not able to flush.An x-ray was taken and it could be seen that the catheter was broken and flushed into the pulmonalis.The port was implanted 4 years ago and was used only once 4 years ago.The device was retrieved via a catheter and forceps.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of complaint history, device history record, and instructions for use was conducted during the investigation.According to info provided, this device will not be returned for evaluation.No images were provided, and no info about the device or the implantation location was provided except for the duration of implantation.Per the complaint, the device was implanted for 4 years.However, the lot number provided in the complaint file was manufactured in 11/2014, which conflicts with the customer report.No manufacturing nonconformities were associated with the provided lot number.There is no evidence to suggest the product was not manufactured to specification.Because no info was provided about the location of the device's implantation, no images were provided, and the device itself was not returned, a full complaint investigation could not be performed.As such, the root cause of the complaint could not be determined with the info provided.

• 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.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4713507
• MDR Text Key: 18089437
• Report Number: 1820334-2015-00206
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• 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 Expiration Date: 10/31/2017
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N124284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2015
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention