MAUDE Adverse Event Report: COOK MEDICAL, LLC. UNIVERSA SOFT URETERAL STENT SET; STENT, URETERAL

Model Number USH-624

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  Injury  

Event Description

Cook urology wire became uncoiled during procedure, fluoroscopy required to determine no retained pieces of wire remained in patient.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK MEDICAL, LLC.; bloomington IN 47404
• MDR Report Key: 16789645
• MDR Text Key: 313827508
• Report Number: MW5116892
• Device Sequence Number: 1
• Product Code: FAD
• 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: 04/17/2023

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
• Device Operator: Health Professional
• Device Model Number: USH-624
• Device Lot Number: 14809257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White