MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX? PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752640
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used in a laser lithotripsy procedure.During the procedure, the stent was fractured.It was noted that a bend in the packaging have caused the damage of the stent.The procedure was completed with another same device and there were no patient complications reported.

• Brand Name: PERCUFLEX? PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22746406
• Report Number: 2124215-2025-54526
• Device Sequence Number: 13042108
• Product Code: FAD
• UDI-Device Identifier: 08714729041191
• UDI-Public: (01)08714729041191(17)280226(10)35946325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: M0061752640
• Device Catalogue Number: M0061752640
• Device Lot Number: 0035946325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 02/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown