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

Model Number	M0061453520
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name block e1: intersection of (b)(6).Block h6: imdrf code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during rigid ureteroscopic lithotripsy procedure, a percuflex ureteral stent was to be used, during preparation, it was found that the stent shaft was broken.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf code a0401 captures the reportable event of stent shaft break.Block h11: investigation results the returned percuflex ureteral stent was analyzed.During the inspection, it was found that the stent shaft was detached and the suture hole was torn, which confirmed the reported event.Based on the most relevant information, the analysis performed to the returned device, it is possible to conclude that this problem 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 can get detached, separated or torn during the preparation affecting the performance of the device.The device history record review was completed, and it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent shaft break and suture hole torn were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on a thorough review of the reported complaint, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that, during rigid ureteroscopic lithotripsy procedure, a percuflex ureteral stent was to be used, during preparation, it was found that the stent shaft was broken.The procedure was completed with another of the same device.No patient complications were 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: 24274426
• Report Number: 2124215-2026-06774
• Device Sequence Number: 10030637
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)280313(10)36070463
• 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): 03/20/2026

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: 0036070463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG