BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6124911 · Received November 23, 2016

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    Report

    Report Number
    2134265-2016-10814
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    October 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER BECAME STUCK ON THE WIRE. AN ANGIOJET® ZELANTEDVT¿ WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN. A NON-BSC WIRE WAS ADVANCED TO THE CHRONIC VENOUS ILIAC OCCLUSION; HOWEVER IT WAS NOTED THAT THE WIRE WAS KINKED. IT TOOK 3 HOURS TO REACH THE LESION WITH THE WIRE. A SOLENT OMNI CATHETER WAS USED; HOWEVER IT WAS DETERMINED THAT THERE WAS NOT ENOUGH CLOT CLEARANCE SO THE ZELANTE CATHETER WAS SELECTED. NO ISSUES WERE NOTED WITH THE SOLENT OMNI CATHETER. THE ZELANTE CATHETER FELT TIGHT GOING THROUGH THE UNSPECIFIED 8F SHEATH. THE DEVICE WAS IN THROMBECTOMY MODE AND GOT GOOD CLOT CLEARANCE. DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT IT WAS STUCK ON THE WIRE. THE DEVICE WAS CUT APART TO RELEASE IT OFF OF THE WIRE TO REMOVE IT FROM THE PATIENT. ALL OF THE CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS NOTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775136 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001

    Patients

    Seq Age Sex Outcome Treatment
    1