BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6176684 · Received December 15, 2016

    Report

    Report Number
    2134265-2016-11624
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 25, 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 MFR.: RETURNED PRODUCT CONSISTED OF A ZELANTE DVT CATHETER SYSTEM WITHOUT THE BAG SPIKE. THERE WAS BLOOD INSIDE THE DEVICE. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND NO DAMAGE OR IRREGULARITIES WERE 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. AN ANGIOJET® ZELANTEDVT¿ CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE RIGHT ILIOFEMORAL VEIN. THE DEVICE WAS PRIMED AND ASPIRATION WAS INITIATED INSIDE THE BODY. HOWEVER, AFTER 18 SECONDS, ASPIRATION STOPPED AND AN ERROR MESSAGE TO PRIME THE CATHETER DISPLAYED ON THE CONSOLE. THEY RE-PRIMED THE CATHETER OUTSIDE AND IT WORKED FOR 6 SECONDS, BUT STOPPED AGAIN. THEY UN-SPIKED THE SALINE BAG, TURNED OFF THE CONSOLE, AND TRIED TO START AGAIN, BUT IT WOULD NOT WORK. THERE WERE NO OBSERVED PHYSICAL ISSUES SUCH AS A LEAK, BREAK, OR KINK. THE PRODUCT WAS REMOVED FROM THE PATIENT WITHOUT ADVERSE EFFECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ZELANTE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING VERY WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. AN ANGIOJET® ZELANTEDVT¿ CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE RIGHT ILIOFEMORAL VEIN. THE DEVICE WAS PRIMED AND ASPIRATION WAS INITIATED INSIDE THE BODY. HOWEVER, AFTER 18 SECONDS, ASPIRATION STOPPED AND AN ERROR MESSAGE TO PRIME THE CATHETER DISPLAYED ON THE CONSOLE. THEY RE-PRIMED THE CATHETER OUTSIDE AND IT WORKED FOR 6 SECONDS, BUT STOPPED AGAIN. THEY UN-SPIKED THE SALINE BAG, TURNED OFF THE CONSOLE, AND TRIED TO START AGAIN, BUT IT WOULD NOT WORK. THERE WERE NO OBSERVED PHYSICAL ISSUES SUCH AS A LEAK, BREAK, OR KINK. THE PRODUCT WAS REMOVED FROM THE PATIENT WITHOUT ADVERSE EFFECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ZELANTE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829351 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19942360

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR