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

Model Number	M0061453520
Medical Device Problem Codes	Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.
Event or Problem Description
It was reported that a percuflex ureteral stent was used in a lithotripsy procedure.During the procedure, it was noticed that the stent was kinked and twisted.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a percuflex ureteral stent was used in a lithotripsy procedure.During the procedure, it was noticed that the stent was kinked and twisted.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Block e1: initial reporter first name, has been updated.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this percuflex ureteral stent underwent a thorough analysis.Visual analysis of the returned device identified that the bladder coil was detached and the shaft was buckled accordioned.Visual and microscopic inspection confirmed that the stent was deformed.The reported issue of kink could not be confirmed.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 issues could be were 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 or renal coil and is removed using excess force, the stent could become detached or separated during preparation, affecting the performance of the device.Additionally, if the positioner is advanced with excess force over the guidewire, the stent could become buckled or accordioned, resulting to 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
• 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: 23722455
• Report Number: 2124215-2025-88981
• Device Sequence Number: 8413424
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)270516(10)33981774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• 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,Followup
• Report Date (Section B): 02/23/2026

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0033981774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 78 KG