MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Percuflex Plus; catheter, biliary, diagnostic

Model Number	M0061752530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6:\ imdrf device code a0401 captures the reportable event of stent shaft break.\ \ block h11:\ the device was not returned for analysis; however, the customer provided a photo.During inspection, it was observed that the shaft was detached.It is possible to conclude that this issue could be caused by operational factors.If the retrieval line gets entangled in the shaft and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.A review of the device history record (dhr) was performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent shaft break was defined in the risk documentation and is documented accordingly.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during transurethral laser lithotripsy and stone removal of the ureter/renal pelvis plus transurethral ureteral stent placement under general anesthesia with endotracheal intubation.During procedure, it was discovered that the stent was broken.The procedure was completed with another of the same stent.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during transurethral laser lithotripsy and stone removal of the ureter/renal pelvis plus transurethral ureteral stent placement under general anesthesia with endotracheal intubation.During procedure, it was discovered that the stent was broken.The procedure was completed with another of the same stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6:\ imdrf device code a0401 captures the reportable event of stent shaft break.

• 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: 50713512
• Report Number: 2124215-2026-48398
• Device Sequence Number: 18656186
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: (01)08714729056812(17)280910(10)37432155
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0037432155
• 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: 08/15/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 09/11/2025
• 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 Age: 60 YR
• Patient Sex: Male