MAUDE Adverse Event Report: POTRERO MEDICAL, INC. ACCURYN SMARTFOLEY UO TEMP TRAY SYSTEM 16FR; CATHETER, RETENTION TYPE, BALLOON

Model Number	FGS-06-UOT.16FST
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Accuryn smartfoley came without catheter.

• Brand Name: ACCURYN SMARTFOLEY UO TEMP TRAY SYSTEM 16FR
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): POTRERO MEDICAL, INC.; 26142 eden landing road; hayward CA 94545
• MDR Report Key: 22113892
• Report Number: 22113892
• Device Sequence Number: 6951043
• Product Code: EZL
• UDI-Device Identifier: 00850019755145
• UDI-Public: (01)00850019755145(17)270728(10)C24122804
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/21/2025
• Report Date (Section F): 05/21/2025

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: FGS-06-UOT.16FST
• Device Catalogue Number: FGS-06-UOT.16FST
• Device Lot Number: C24122804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/21/2025