BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1141065 · Received August 29, 2008

    Report

    Report Number
    2182269-2008-00199
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 29, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 INFORMATION 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 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 THAT AN ANGIO-SEAL WAS SELECTED FOR USE. FIVE DAYS LATER, THE PATIENT RETURNED TO THE PHYSICIAN OFFICE WITH A HEMATOMA AND FEVER. NINE DAYS, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) AND THE HEMATOMA WAS STILL PRESENT. TWO DAYS, THE PATIENT WENT TO THE OPERATING ROOM FOR REMOVAL OF THE ANGIO-SEAL. THE PHYSICIAN NOTED THAT THE ANGIO-SEAL WAS NOT ATTACHED TO THE VESSEL WALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention