BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22543584 · Received July 18, 2025

    Report

    Report Number
    2124215-2025-48056
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE ELECTROPHYSIOLOGY STUDY (EPS) ATRIAL FIBRILLATION ABLATION PROCEDURE, THE FARADRIVE STEERABLE SHEATH CLEAR, WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT TRANSSEPTAL ACCESS WAS OBTAINED USING A VERSACROSS FIXED SHEATH. MAPPING THE LEFT ATRIUM WAS PERFORMED THROUGH THE VERSACROSS FIXED SHEATH WITH AN ABBOTT HD GRID CATHETER. FOLLOWING MAP CREATION, THE HD GRID WAS REMOVED FROM THE FIXED SHEATH. THE PHYSICIAN EXCHANGED THE VERSACROSS FIXED SHEATH OVER THE VERSACROSS WIRE WITH THE FARADRIVE SHEATH. AFTER THE EXCHANGE, THE FARAWAVE CATHETER AND MERIT MEDICAL INQWIRE GUIDEWIRE WERE ADVANCED TO JUST PAST THE HANDLE OF THE FARADRIVE. THE FARADRIVE SHEATH WAS ASPIRATED WITH A 20 ML SYRINGE. BUBBLES WERE OBSERVED IN THE ASPIRATION SYRINGE DURING ASPIRATION. ANOTHER ATTEMPT WAS MADE TO ASPIRATE THE FARADRIVE SHEATH WITH A 10 ML SYRINGE WITH THE FARAWAVE IN THE SAME LOCATION, JUST PAST THE HANDLE OF THE FARADRIVE. THIS AGAIN RESULTED IN AIR BUBBLES BEING OBSERVED IN THE 20 ML SYRINGE BUT NOT PATIENT. THE TROUBLESHOOTING STEPS INCLUDED MULTIPLE ATTEMPTS TO ASPIRATE THE FARADRIVE WITH A SYRINGE, YET NO IMPROVEMENT. THE PHYSICIAN OPTED TO REMOVE THE FARAWAVE FROM THE FARADRIVE AND EXCHANGE THE FIRST FARADRIVE OVER THE VERSACROSS WIRE WITH A SECOND FARADRIVE. NO ISSUES WERE ENCOUNTERED WITH THE SECOND FARADRIVE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS NOTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277568 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL13944 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown