BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1053624 · Received May 23, 2008

    Report

    Report Number
    1016427-2008-00154
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    May 7, 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 EVAL AND TESTING. ADDITIONAL INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    BLOOD FLOW BECAME SLOW DURING THE STENTING PROCEDURE AT THE POSITION OF THE FILTER BASKET. THE PHYSICIAN CONDUCTED SUCTION NEAR THE BASKET, AND RETRIEVED DEBRIS. THE BLOOD FLOW RECOVERED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PT IS A MALE. THE TARGET VESSEL WAS THE CAROTID ARTERY (SIDE UNK). THERE IS NO INFO REGARDING THE CHARACTERISTICS OF THE VESSEL. THERE WAS NO DIFFICULTY POSITIONING THE FILTER BASKET DISTAL TO THE LESION. THERE WAS NO DIFFICULTY PLACING THE PRECISE STENT. IT WAS NOTED THAT THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE SLOW-FLOW WAS THE DEBRIS THAT WAS CAUGHT IN THE BASKET. THERE WERE NO NEUROLOGIC SYMPTOMS TO THE PT, AND THE PT WAS NEUROLOGICALLY INTACT AT THE END OF THE PROCEDURE.

    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 72 YR Hospitalization| L| R PRECISE: LOT 13137936