MAUDE Adverse Event Report: COOK INCORPORATED FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; STENT, URETERAL

Model Number	G46440
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of acute on chronic kidney disease.Procedure: cystoscopy, retrograde, pyelogram, ureteroscopy and left jj stent placement.After placing a ureteral stent, it was observed that the metal tip was off the pusher and the glidewire was frayed.Metal tip was observed on the set-up tray so the tip was not in the glidewire when used on the patient.No known harm to patient.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 20144625
• Report Number: 20144625
• Device Sequence Number: 19892844
• Product Code: FAD
• UDI-Device Identifier: 00827002464407
• UDI-Public: (01)00827002464407(17)270610(10)16099407
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/02/2024
• Report Date (Section F): 08/02/2024

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 Model Number: G46440
• Device Catalogue Number: 133626-01
• Device Lot Number: 16099407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/02/2024