BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3242877 · Received July 19, 2013

    Report

    Report Number
    2182269-2013-00058
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE ARE 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 AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL DEVICE HAS NOT BEEN ESTABLISHED IN PTS WITH UNCONTROLLED HYPERTENSION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA).

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE IN THE RIGHT FEMORAL ARTERY. NO PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. APPROX 24 HOURS POST-DEPLOYMENT WHILE STILL IN THE HOSPITAL, THE PT DEVELOPED A GROIN HEMATOMA WHICH REQUIRED SURGICAL INTERVENTION THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338235 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610132 4021014

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R