BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE VIP

    MDR report key: 1250677 · Received December 2, 2008

    Report

    Report Number
    2182269-2008-00328
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 1, 2008
    Report Date
    December 2, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT IF COLLAGEN DEPOSITION INTO THE ARTERY AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS PROCEDURE AN ANGIO-SEAL VIP WAS DEPLOYED. APPROXIMATELY 1 WEEK LATER, THE PATIENT CONTACTED THE PHYSICIAN DUE TO A COMPLICATION. THE PATIENT UNDERWENT SURGICAL INTERVENTION AND THE COLLAGEN WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE VIP ANGIO-SEAL DEVICE VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R