BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 1071321 · Received July 8, 2008

    Report

    Report Number
    9616695-2008-00108
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE LOT HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNABLE TO RETRIEVE EPD WITH RECOVERY CATHETER. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, DURING ATTEMPTED RECOVERY OF THE EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD), THE PHYSICIAN WAS UNABLE TO ADVANCE THE RECOVERY CATHETER TO RETRIEVE THE FILTER. THE BAREWIRE REMAINED IN PLACE AND THE SLIP CATHETER WAS USED TO RETRIEVE THE EPD SUCCESSFULLY. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR GALWAY NA 500284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN| XACT STENT X2