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

Model Number	M006175253050
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable investigation result of stent torn inside the patient.Device code a040601 captures the reportable investigation result of stent buckled 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 of the returned device identified that the stent bladder coil was buckled and the tip was torn, however the ro marker looks in good condition.The reported allegation of stent difficult to view under fluoroscopy could not be confirmed.The positioner was returned.However, the suture was not 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.Probably some manipulation during the procedure could have caused torn and buckled on the device.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used in a retrograde intrarenal surgery procedure in the left ureter.During the procedure, when the stent was pushed through the guidewire, it could not be seen under the fluoroscopy.The physician attempted to reposition the stent, however, only the guidewire can be seen under fluoroscopy.The procedure was completed with another of the same device and there were no patient complications reported.This event has been deemed reportable based on the investigation finding that the stent was torn and buckled inside the patient.Please see block h11 for full investigation details.

• 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: 24284824
• Report Number: 2124215-2026-07035
• Device Sequence Number: 18222271
• Product Code: FAD
• UDI-Device Identifier: 08714729339977
• UDI-Public: (01)08714729339977(17)280310(10)36950172
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 06/11/2026

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: M006175253050
• Device Catalogue Number: M006175253050
• Device Lot Number: 0036950172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: 54 YR
• Patient Sex: Male