MAUDE Adverse Event Report: COOK INC. POLLACK OPEN-END FLEXITIP URETERAL CATHETER; URETERAL CATHETER, GENERAL & PLASTIC SURGERY

Model Number 021305

Device Problem Break (1069)

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

Event Date 09/27/2018

Event Type  Injury  

Event Description

A piece of the pollack catheter sheared off during case.It is believed that all pieces were removed from the pt.This is now the 3rd device issue with this product, we are looking to replace for safety and quality reasons.

• Brand Name: POLLACK OPEN-END FLEXITIP URETERAL CATHETER
• Type of Device: URETERAL CATHETER, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC. ; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7964897
• MDR Text Key: 123833715
• Report Number: MW5080534
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: 021305
• Device Catalogue Number: G14521
• Device Lot Number: 9048939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR