BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1201468 · Received October 16, 2008

    Report

    Report Number
    2182269-2008-00234
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CARDIAC PROCEDURE, AN ANGIO-SEAL WAS DEPLOYED. AFTER DEPLOYMENT THE PT DEVELOPED A HEMATOMA. THE BLEEDING CAUSED A VAGAL EPISODE WHICH REQUIRED RESUSCITATION. THE PT WAS REPORTEDLY RECOVERED. THE PT WAS TAKING ANTI-COAGULANT MEDICATIONS OF HEPARIN, REOPRO, ASCAL, AND PLAVIX, ALL DOSES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2659405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention