MAUDE Adverse Event Report: COOK, INC. TORCON NB ADVANTAGE BEACON TIP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G11377

Device Problems Break (1069); Fracture (1260); Nonstandard Device (1420); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2016

Event Type  malfunction  

Event Description

When pulling back the catheter the beacon tip broke off, lodging within the soft tissue tract leading to the kidney.This was picked up on a ct scan performed for a different medical reason.The tip was removed successfully.Manufacturer response for diagnostic angiography catheter, beacon tip (per site reporter): this is one of the product codes that was involved in a cook product recall.The time of implantation occurred prior to notification by cook of the recall.The recall was for the type of product problem as described in this report.Language from recall for reference: cook medical has initiated a global, voluntary recall of all catheters with beaconip technology.This recall includes all lots of catheters with the beacon tip technology.The catheters were recalled on april 15, 2016 due to complaints of tip splitting and/or fracture.The u.S.Food and drug administration (fda) has not yet classified the recall.

• Brand Name: TORCON NB ADVANTAGE BEACON TIP CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5771785
• MDR Text Key: 48845104
• Report Number: 5771785
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G11377
• Device Catalogue Number: HNBR5.0-38-65-P-NS-TEGT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR