BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOTWIRE¿ RF GUIDEWIRE

    MDR report key: 21688513 · Received March 25, 2025

    Report

    Report Number
    3029895042-2025-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 23, 2025
    Manufacturer
    ATRAVERSE MEDICAL
    Product Code
    DXF
    PMA / PMN Number
    K240900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, THE COMPANY WAS NOTIFIED OF A MALFUNCTION WITH ITS HOTWIRE (PIGTAIL) DEVICE THAT OCCURRED ON (B)(6) 2025. SPECIFICALLY, DETACHMENT OF THE DISTAL TIP OF THE DEVICE INTRAOPERATIVELY RESULTED IN A SLIGHT PROLONGATION OF THE SURGICAL PROCEDURE. PATIENT WAS ROUTINELY DISCHARGED ON TIME AS SCHEDULED. NO PATIENT INJURY NOR COMPLICATIONS HAVE BEEN REPORTED. A FOLLOW-UP MDR MAY BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE AS NEEDED. COMPLAINT WAS CONFIRMED. LOT HISTORY REVIEW: REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER 25-0091 HAS BEEN MADE FOR THE SAME ISSUE. FAILURE MODE WILL CONTINUE TO BE MONITORED FOR ANY UNACCEPTABLE INCREASE IN TREND.

    Description of Event or Problem · 0

    75 Y.O. FEMALE PATIENT WAS SCHEDULED FOR FIRST TIME AFIB ABLATION. PHYSICIAN GOT FEMORAL ACCESS AND THEN USED PERCLOSE VASCULATURE SYSTEM. THE PHYSICIAN THEN PUT IN AN 8FR SHORT SHEATH AND INTRODUCED HOTWIRE THROUGH THAT SHEATH. THE PHYSICIAN ADVANCED THE DISTAL END OF HOTWIRE INTO THE RA-IVC JUNCTION, AND EXCHANGED THE 8FR SHEATH FOR A 13FR AGILIS NXT STEERABLE INTRODUCER DUAL REACH. WHILE TRYING TO ADVANCE HOTWIRE, THE PHYSICIAN NOTICED THAT WHILE THE PROXIMAL END OF THE WIRE WAS ADVANCING, THE DISTAL PIGTAIL PORTION OF THE WIRE WAS NOT MOVING ON ICE. THE PHYSICIAN THEN REMOVED HOTWIRE AND NOTICED THAT THE DISTAL TIP WAS NO LONGER ATTACHED AND STILL IN THE PATIENT. THIS WAS CONFIRMED ON ICE AND FLUORO. THE PHYSICIAN THEN USED A SNARE TO RETRIEVE THE DISTAL END FROM THE RA, AND REMOVE IT THROUGH THE SHEATH AND THE PATIENT. THE PHYSICIAN CONFIRMED USING XRAY THAT THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE CASE PROCEEDED NORMALLY AND PVI WAS COMPLETED. AT THE END OF THE CASE, NO EFFUSION WAS SEEN, AND THE PHYSICIAN DID NOT REPORT ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719617 HOTWIRE¿ RF GUIDEWIRE HOTWIRE DXF ATRAVERSE MEDICAL 901018 25-0091

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention