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

Model Number	M0061752520
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation, the percuflex plus urethral stent medical device was transferred to the surgical table.Upon opening the sterile primary packaging, it was found that the stent was broken into two pieces along the shaft.The procedure was completed with another of the same device and there were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the information available the cause that contributed to the reported event cannot be established.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: correction: the event reported under mfr report number 2124215-2025-79663 was sent in error.Additional information was received from the complainant on november 24, 2025, clarified that the stent coil was detached, occurred outside the patient.Therefore, this is considered non-reportable.
Event or Problem Description
It was reported that during the preparation, the percuflex plus urethral stent medical device was transferred to the surgical table.Upon opening the sterile primary packaging, it was found that the stent coil was detached.The procedure was completed with another of the same device and there were no known 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: 23480503
• Report Number: 2124215-2025-79663
• Device Sequence Number: 10228873
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: (01)08714729056805(17)270930(10)34958056
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0034958056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: Unknown