BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6152219 · Received December 7, 2016

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    Report

    Report Number
    2134265-2016-11259
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED IT WAS OBSERVED THAT THE BLUE VENT THAT IS ATTACHED TO THE BAG SPIKE WAS MISSING. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE CONSOLE FUNCTIONAL TESTING SHOWED ¿CHECK SALINE¿ ERROR. DUE TO THE VENT MISSING A FUNCTIONAL TEST COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS A SUPPLIER DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-11260. A LOSE OF ASPIRATION OCCURRED DURING THE PROCEDURE. DURING TREATMENT OF A DEEP VEIN THROMBOSIS WITH A ANGIOJET® ZELANTEDVT¿, AFTER RUNNING FOR 133 SECONDS, RECEIVED A CHECK SALINE SUPPLY MESSAGE AND STOPPED ASPIRATION. THE CATHETER WAS RESET BUT THE SAME MESSAGE OCCURRED. THE CATHETER WAS SWITCHED OUT FOR ANOTHER ANGIOJET® ZELANTEDVT¿, WHICH RAN FOR 23 SECONDS BEFORE THE ANGIOJET CONSOLE RECEIVED AN ERROR AND STOPPED ASPIRATION. THE CATHETER WAS ADJUSTED BUT THE SAME THING OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801792 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19636304

    Patients

    Seq Age Sex Outcome Treatment
    1