BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZELANTEDVT CLOTHUNTER

    MDR report key: 19644958 · Received July 1, 2024

    Report

    Report Number
    2124215-2024-39641
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE TARGET LOCATION WAS LOCATED IN THE SUBCLAVIAN VEIN. GENERAL ANESTHESIA WAS USED. A ZELANTEDVT CLOTHUNTER AND ANGIOJET ULTRA SYSTEM CONSOLE WERE SELECTED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, WHILE THE ANGIOJET CONSOLE WAS IN POWERPULSE MODE, FLUID FLOW BACK OCCURRED. FLUID WAS COLLECTING THE IN THE COLLECTION BAG. THE CATHETER WAS REMOVED, AND THE CONSOLE MODE WAS SWITCHED TO THROMBECTOMY AND THE CATHETER WAS RE-PRIMED. HOWEVER, WHEN POWERPULSE WAS RESTARTED, A CHECK SALINE SUPPLY ERROR MESSAGE OCCURRED. THE CATHETER WAS EXCHANGED FOR A NEW DEVICE, SAME MODEL. FOUR ATTEMPTS WERE MADE TO PRIME THIS CATHETER BUT THEY WERE UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545089 ZELANTEDVT CLOTHUNTER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW BOSTON SCIENTIFIC CORPORATION 45027 0033796695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown