BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1061493 · Received June 16, 2008

    Report

    Report Number
    1016427-2008-00172
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION; HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT WHILE PREPPING THE ANGIOGUARD RX, THE STAFF TRIED TO ADVANCE THE DEVICE INTO THE SHEATH; HOWEVER, THE "WIRE WOULD NOT ADVANCE AND BECAME DISLODGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70707504

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK