BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1241280 · Received November 21, 2008

    Report

    Report Number
    1016427-2008-00298
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    June 18, 2008
    Report Date
    October 30, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBER 9610978-2008-00262.

    Description of Event or Problem · 1

    AS REPORTED BY THE AFFILIATE, DURING A PTA PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, AFTER THE PRE-DILATATION WITH THE AMIIA BALLOON, THE BLOOD FLOW BECAME SLOW. THE PHYSICIAN SUCTIONED BLOOD FROM AROUND THE TARGET LESION. THE BLOOD FLOW RECOVERED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ADVERSE EVENTS. THERE WAS MILD CALCIFICATION IN THE LESION AND NO VESSEL TORTUOSITY. THE PRE-PROCEDURE STENOSIS WAS 60% AND THE VESSEL DIAMETER BEYOND THE LESION WAS 4.6 MM. WHEN THE PHYSICIAN SUCTIONED BLOOD AROUND THE TARGET LESION, IT ALSO INVOLVED THE DEBRIS IN THE ANGIOGUARD FILTER BASKET. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. THE PRODUCTS (AMIIA AND ANGIOGUARD) WERE PROPERLY INSPECTED AND PREPPED PRIOR TO INSERTION AS PER THE IFU. THERE WAS ALSO NO DIFFICULTY PLACING THE ANGIOGUARD IN THE AND THE FILTER BASKET HAD GOOD WALL APPOSITION WHEN POSITIONED DISTAL TO THE VESSEL.

    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 70108520

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R AMIIA BALLOON