BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1220487 · Received November 4, 2008

    Report

    Report Number
    1016427-2008-00286
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    May 1, 2008
    Report Date
    October 9, 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

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2008-02596. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE ANGIOGUARD'S DELIVERY AND THE STENT PLACEMENT WERE SUCCESSFUL. A SPASM OCCURRED AFTER THE PRECISE STENT WAS PLACED. AS THE BLOOD FLOW STOPPED, THE PHYSICIAN SUCTIONED THE BLOOD AND THE FLOW RECOVERED NORMALLY. THE MEDICINE (NITROGLYCERIN) WAS ADMINISTERED AT A DOSE OF 100UG FOR THE SPASM. THERE WAS NO NEUROLOGICAL SYMPTOM ON THE PT. EVENTUALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS RIGHT CAROTID ARTERY. THERE WAS NO VESSEL CALCIFICATION. THERE WERE 70% OF STENOSIS AND MILD TORTUOSITY. THE PT IS A FEMALE.

    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 71 YR Required Intervention