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

Model Number	M0061752720
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a lithotripsy procedure.During unpacking, it was discovered a part of the shaft was fractured, and the tip of the stent was detached.The procedure was completed with another percuflex plus stent and no patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.Updated b5 based on the additional information received on march 7, 2025, stating that the pigtail coil was detached and not the along the shaft.Correction to block d4: unique identifier (udi) #, and block h6: device code.The complaint was originally assessed initially for stent shaft break.Additional information was received on march 7, 2025, via gfe response providing the information that only the pigtail coil was detached and not along the shaft.Therefore, this is no longer considered as a reportable event.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a lithotripsy procedure.During unpacking, it was discovered that the part of the pigtail coil was detached, and the tip of the stent was detached.The procedure was completed with another percuflex plus stent and no patient complications were 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: 21540018
• Report Number: 2124215-2025-13728
• Device Sequence Number: 17906098
• Product Code: FAD
• UDI-Device Identifier: 08714729056836
• UDI-Public: (01)08714729056836(17)270417(10)33847885
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: M0061752720
• Device Catalogue Number: M0061752720
• Device Lot Number: 0033847885
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 04/17/2024
• 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: Male