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

Model Number	M0061752530
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percuflex plus ureteral stent was placed into the patient during a lithotripsy on ureter with flex procedure in the kidney.Post procedure, the patient felt that the stent was out of the urethra 4 hours after the stent was implanted.Another procedure was performed to remove the stent, and it was noticed that the stent was straight and was reformed.The stent was successfully removed and was replaced with another of the same device.There were no patient complications reported.A media and a photo of the complaint device was provided and showed that the stent did not coil and was kinked.
Additional Manufacturer Narrative
Block h6: device code a010402 captures the reportable event of stent migration.Device code a0406 captures the reportable event of stent kinked inside the patient.Device code a04 captures the reportable event of coil memory inside the patient.Impact code f1901 captures the reportable event of additional surgery.

• 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: 24049783
• Report Number: 2124215-2026-02066
• Device Sequence Number: 21296163
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: (01)08714729056812(17)270920(10)34896673
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0034896673
• 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: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown