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

Model Number	M0061453520
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a04060 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 for right renal stone procedure in the right kidney.During the procedure and inside the patient, it was noticed that the stent was wrinkled.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a04060 captures the reportable event of stent buckled material inside the patient.Block h11: investigation analysis the complaint device was not returned for evaluation.Based on the information available and the analysis performed, there was no evidence from the manufacturing review to indicate that the device malfunctioned due to a process related defect.The most probable cause of the reported event could not be established due to the lack of physical evidence.Without a device evaluation or additional objective evidence, the potential causes that may have contributed to the event remain unknown.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and verified that the events stent/delivery system difficult to advance and stent kinked are included in the product risk documentation.These event types have been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the available information, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex ureteral stent was used in a lithotripsy for right renal stone procedure in the right kidney.During the procedure and inside the patient, it was noticed that the stent was wrinkled.The procedure was completed with another of the same device and there were no patient complications reported.

• 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: 24492884
• Report Number: 2124215-2026-11575
• Device Sequence Number: 12006982
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)280615(10)36759852
• 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): 05/22/2026

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: 0036759852
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 06/16/2025
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 61 KG