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

Catalog Number	024103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7426706
• Report Number: 1820334-2018-01101
• Device Sequence Number: 11149112
• Product Code: GBL
• UDI-Device Identifier: 00827002140424
• UDI-Public: (01)00827002140424(17)180903(10)6176281
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 024103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO