MAUDE Adverse Event Report: COOK INC ROUND TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 024103

Device Problems Bent (1059); Fracture (1260); Failure to Advance (2524)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol capa (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that the physicians used the round tip ureteral catheter to enter the pediatric cystoscope in order to check the ureteral orifice.The physician was unable to push the catheter forward as a result of advancement difficulty when entering the cystoscope.After several failed attempts, the physician removed the catheter and noted that it was bent and fractured.It was further noted that the catheter was bent backwards and partially severed at a sideport that was 3 cm (centimeters) from the distal tip.The physician expressed that the catheter was too soft and the material was not very good.This product problem reportedly occurred prior to patient contact and there was no impact to the patient or end user.

• Brand Name: ROUND TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7426706
• MDR Text Key: 105764864
• Report Number: 1820334-2018-01101
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002140424
• UDI-Public: (01)00827002140424(17)180903(10)6176281
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 024103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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 Age: 6 MO