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

Model Number	M0061453620
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during the procedure, the physician was about to place a ureteral stent for the patient, but when the stent was unpackaged, it was found that the ureteral stent was fractured.Therefore, a new ureteral stent was used.
Additional Manufacturer Narrative
Block h6: updated imdrf device code a0414 captures the material split, torn or cut.Block h11: the percuflex ureteral stent was not returned for analysis, but an additional information response from the customer provided the information that, the ureteral stent was torn from site of the thread hole and not broken into two pieces along the shaft.Although this can result in a clinically insignificant delay of the procedure, this event is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, boston scientific no longer considers this to be a reportable event.Block h6 has been updated based on the additional information received on june 30, 2025.
Event or Problem Description
It was reported that during the procedure, the physician was about to place a ureteral stent for the patient, but when the stent was unpackaged, it was found that the ureteral stent was fractured.Therefore, a new ureteral stent was used.

• 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: 22324485
• Report Number: 2124215-2025-41182
• Device Sequence Number: 12964877
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: (01)08714729040330(17)270515(10)34038926
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: M0061453620
• Device Catalogue Number: M0061453620
• Device Lot Number: 0034038926
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 05/15/2024
• 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: 71 YR
• Patient Sex: Male