BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1172328 · Received April 30, 2008

    Report

    Report Number
    1016427-2008-00127
    Event Type
    Injury
    Date Received
    April 30, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PT WAS ADMITTED FOR CAROTID ARTERY STENTING. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY. THERE WAS NO CALCIFICATION BUT THE VESSEL WAS MILDLY TORTUOUS WITH 90% STENOSIS. AN ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM WAS POSITIONED AND DEPLOYED WITHOUT DIFFICULTY. AFTER POST-DILATATION (BALLOON: SUBMARINE, ST. JUDE MEDICAL. SIZE UNK), THE PT MOVED HIS BODY AND BLOOD FLOW STOPPED. DEBRIS WAS SUCTIONED FROM THE ANGIOGUARD FILTER BASKET WITH THROMBUSTER CATHETER (KANEKA MEDICAL CO.), AND THE FLOW RECOVERED NORMAL. AFTER THE PROCEDURE, THE PT DEVELOPED MILD HEMIPLEGIA DUE TO TIA. THE PHYSICIAN COMMENTED THAT THE DEBRIS COULD BE FLOWED DISTAL AND CAUSED TIA. THE PT IS IN STABLE CONDITION, AND NO TREATMENT IS GIVEN FOR THE TIA. THERE ARE NO OTHER PT, LESION OR PROCEDURAL DETAILS AVAILABLE.

    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 70108515

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R BALLOON: SUBMARINE