MAUDE Adverse Event Report: COOK INCORPORATED OPEN-END URETERAL CATHETER; CATHETER, URETERAL, GENERAL, AND PLASTIC SURGERY

Lot Number 7813287

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

While using catheter during a cystic procedure, the guidewire pushed loose plastic particles out of the catheter and into the pt's bladder.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: CATHETER, URETERAL, GENERAL, AND PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN 47404
• MDR Report Key: 6971253
• MDR Text Key: 90235436
• Report Number: MW5072902
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2020
• Device Lot Number: 7813287
• 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 Age: 34 YR