BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22631454 · Received July 28, 2025

    Report

    Report Number
    2124215-2025-50475
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 30, 2025
    Report Date
    November 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: VISUAL INSPECTION REVEALED NO OUTER ABNORMALITIES WERE NOTED. THE SHEATH WAS LEAK TESTED, AND THE SHEATH PASSED ALL LEAK TESTING. THE VALVES WERE INSPECTED USING MICROSCOPY. NO SIGNIFICANT DAMAGE WAS NOTED, AND NO ABNORMALITIES WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING PREPARATION NO ABNORMALITIES WAS NOTED DURING PREPARATION OF THE SHEATH. IT WAS MENTIONED THAT AIR CONTINUED TO ASPIRATED FROM THE SHEATH. THUS THE SHEATH WAS REPLACED WITH SAME MODEL SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SYRINGE PUMP OF NON BOSTON SCIENTIFIC PUMP IRRIGATION METHOD WAS USED WITH A FLOW RATE OF 30ML/H. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING PREPARATION NO ABNORMALITIES WAS NOTED DURING PREPARATION OF THE SHEATH. IT WAS MENTIONED THAT AIR CONTINUED TO ASPIRATED FROM THE SHEATH. THUS THE SHEATH WAS REPLACED WITH SAME MODEL SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SYRINGE PUMP OF NON BOSTON SCIENTIFIC PUMP IRRIGATION METHOD WAS USED WITH A FLOW RATE OF 30ML/H. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507816 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL13974 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male