MAUDE Adverse Event Report: COOK, INC. UNIVERSA; CATHETER, RETENTION TYPE, BALLOON

Model Number USH-624-RT1

Device Problem Failure to Advance (2524)

Patient Problem Pain (1994)

Event Date 10/09/2015

Event Type  malfunction  

Event Description

Stent would not advance with the guide wire.The guide wire was going through larger holes in the stent.It was not coiling in the bladder correctly.Patient pain also increases urge to urinate, requiring medication.This has reportedly occurred multiple times - md reports lot of friction and procedure takes longer.

• Brand Name: UNIVERSA
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK, INC.; 750 daniels way,; bloomington IN 47402
• MDR Report Key: 5196942
• MDR Text Key: 30214703
• Report Number: 5196942
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: USH-624-RT1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1