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

Model Number	M0061752530
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a retrograde intrarenal surgery procedure.During unpacking, it was found that the tip and along that shaft of the stent was fractured.The procedure was completed with another of the same device.There were no patient complications 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.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this percuflex plus ureteral stent underwent a thorough analysis.Visual inspection of the device identified that the stent bladder coil was detached, and the suture hole was torn.The positioner and suture were also returned.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.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent could get detached/separated, and torn during preparation, affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a retrograde intrarenal surgery procedure.During unpacking, it was found that the tip and along that shaft of the stent was fractured.The procedure was completed with another of the same device.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: 23556344
• Report Number: 2124215-2025-81852
• Device Sequence Number: 21289304
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 0034702890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 08/27/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/06/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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