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

Model Number	M0061751980
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used in an indwelling flexible ureteroscope for renal calculi procedure.During the procedure and inside the patient, it was noticed that the stent could not be advanced.The procedure was completed with another of the same device and there was no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable investigation result of stent buckled material inside the patient.Block h11: investigation analysis: upon receipt at our quality assurance laboratory, this percuflex plus ureteral stent underwent a thorough analysis.Visual analysis identified that the shaft and the coil were buckled.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of stent/delivery system difficult to advance and stent buckled/accordion were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the information available and analysis results, the reported allegation of stent difficult to advance could be confirmed.It is possible to conclude that this issue could be caused by operational factors.If the positioner is advanced with excess force over the guidewire the stent could get buckled/accordioned resulting in a difficulty/unable to advance the stent to the target site.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 25210923
• Report Number: 2124215-2026-26773
• Device Sequence Number: 10433297
• Product Code: FAD
• UDI-Device Identifier: 08714729067627
• UDI-Public: (01)08714729067627(17)270603(10)34156819
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: M0061751980
• Device Catalogue Number: M0061751980
• Device Lot Number: 0034156819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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