BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6142479 · Received December 2, 2016

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    Report

    Report Number
    2134265-2016-10881
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A ZELANTE DVT CATHETER SYSTEM AND NO OTHER DEVICES. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND NO DAMAGE OR IRREGULARITIES IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE CONSOLE. FUNCTIONAL TESTING SHOWED A LEAK AT THE MALE CONNECTOR WITH FEMALE LUER. FLUID LEAKING FROM THE CONNECTOR IS IN INDICATION THAT THE OUTLET ADAPTER SEAL FAILED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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 DESIGN CONSTRAINT OF THE PRODUCT. (B)(4)..

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ERROR MESSAGE OCCURRED DURING ASPIRATION. AN ANGIOJET® ZELANTEDVT¿ CATHETER WAS BEING USED TO TREAT THROMBOSIS IN THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A COUPLE OF PASSES WITH THE CATHETER, AN ERROR TO CHECK SALINE CONNECTION OCCURRED. THE PROCEDURE WAS COMPLETED WITH A SOLENT OMNI. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ERROR MESSAGE OCCURRED DURING ASPIRATION. AN ANGIOJET ZELANTE DVT CATHETER WAS BEING USED TO TREAT THROMBOSIS IN THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A COUPLE OF PASSES WITH THE CATHETER, AN ERROR TO CHECK SALINE CONNECTION OCCURRED. THE PROCEDURE WAS COMPLETED WITH A SOLENT OMNI. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE UPON COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792402 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19830197

    Patients

    Seq Age Sex Outcome Treatment
    1