BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1021182 · Received March 28, 2008

    Report

    Report Number
    1016427-2008-00092
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 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

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE BLOOD FLOW STOPPED TEMPORARILY AFTER POST-DILATATION OF THE PRECISE STENT. HOWEVER, THE FLOW RECOVERED NORMAL AFTER THE DEBRIS WAS SUCTIONED. THE PT WAS NEUROLOGICALLY INTACT FOLLOWING THE PROCEDURE, AND CURRENTLY IS IN STABLE CONDITION. THE LESION WAS SUCCESSFULLY TREATED. THE PT WAS A MALE. THE TARGET LESION WAS CAROTID ARTERY (NO FURTHER DETAIL IS PROVIDED). THERE IS NO INFO ABOUT THE TARGET CHARACTERISTICS. THE RATE OF STENOSIS IS UNK. THE PT WAS ANTICOAGULATED (MEDS UNK). THERE WAS NO MALFUNCTION OF THE ANGIOGUARD OR THE STENT.

    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 70907507

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R ASPIRATION CATHETER| PRECISE STENT