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

Model Number	M0061453620
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 unpacking, it was found that the stent was fractured.The procedure was completed with another of the same device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: additional information was received stating that the coil or pigtail was detached from the end of the stent, outside the patient.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 6, 2025.
Event or Problem Description
It was reported that during unpacking, it was found that the stent was fractured.The procedure was completed with another of the same device and the patient condition following the procedure was stable.

• 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: 22146389
• Report Number: 2124215-2025-36096
• Device Sequence Number: 15570563
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: (01)08714729040330(17)270906(10)34794551
• 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): 07/03/2025

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: 0034794551
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 09/06/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 65 KG