BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1221225 · Received November 4, 2008

    Report

    Report Number
    3003681312-2008-00118
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE LIMITED INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE IFU ALSO INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LEFT HEART CATHETERIZATION, AN 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY. THE PT EXPERIENCED BLEEDING IN THE LEFT GROIN FOLLOWING THE PROCEDURE. THE SURGICAL REPORT STATED THAT THE RETROPERITONEAL HEMATOMA EXTENDED FROM THE INGUINAL REGION TO THE DIAPHRAGM IN THE LEFT REGION. THE PT REC'D FOUR UNITS OF BLOOD AND WENT INTO RENAL FAILURE, NO ADDITIONAL INFO WAS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention HEPARIN| PLAVIX