BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1221558 · Received November 5, 2008

    Report

    Report Number
    1016427-2008-00287
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED FOR STENTING OF THE ICA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE VESSEL CHARACTERS OR THE PATIENT. AN ANGIOGUARD DEVICE WAS ADVANCED BEYOND THE TARGET SITE AND WAS DEPLOYED WITHOUT DIFFICULTY. TWO PRECISE STENTS, A 10 X 30MM AND A 10 X 40MM, WERE DEPLOYED IN THE TARGET SITE WITHOUT COMPLICATIONS. AFTER THE PHYSICIAN WITHDREW THE ANGIOGUARD OUT OF THE PATIENT, HE FOUND THAT A PART OF THE FILTER MEMBRANE HAD SEPARATED FROM THE STRUTS. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70308510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 2 PRECISE STENTS