MAUDE Adverse Event Report: COOK UROLOGICAL INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 021305

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Type  Injury  

Event Description

The surgeon was presented with a 5fr access lumen into the pediatric scope.The catheter was used seemingly fine without difficulty; however, upon pulling the catheter back out of the scope, the tip of the catheter broke off inside the patient.The part of the catheter that was pulled out looked like it was cracked.The surgeon went back inside the patient and removed the "broke off" portion of the catheter without difficulty.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The surgeon went back inside the patient and removed the "broke off" portion of the catheter without difficulty.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3980968
• MDR Text Key: 20457623
• Report Number: 1820334-2014-00338
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 021305
• Device Lot Number: U2478144
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2014
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR