BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3844724 · Received May 21, 2014

    Report

    Report Number
    3844724
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    January 28, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS DEPLOYED AND THE SUTURES WERE NOT CAPTURED PROPERLY, THE DEVICE WAS ABANDONED, AND A DIFFERENT CLOSURE DEVICE WAS USED. PERCLOSE DEVICE FAILED MAINLY DUE TO PATIENT ANATOMY (5MM FEMORAL THAT WAS PROBABLY FIBROTIC) AND POSSIBLE OPERATOR ERROR. DEVICE PULLED BACK AFTER FOOTPLATE OPENED INTO POSITION WITH MODEST RESISTANCE, NEEDLES DEPLOYED BUT FAILED TO CONTACT SUTURE, SO FOOTPLATES WERE NOT ALIGNED PROPERLY ON INNER SURFACE OF VESSEL, DEVICE REMOVED OVER A WIRE.======================MANUFACTURER RESPONSE FOR PERCLOSE PROGLIDE 6FR, PERCLOSE PROGLIDE 6FR (PER SITE REPORTER).======================REP FROM ABBOTT WILL BE SPENDING A WEEK AT THE HOSPITAL TO OBSERVE DEPLOYMENTS AND FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303608 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC 12673 31116K1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR