BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3190167 · Received June 21, 2013

    Report

    Report Number
    2182269-2013-00048
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    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 REC'D, 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.

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED A 6F ANGIO SEAL VIP WAS SELECTED FOR USE. BLEEDING OCCURRED FOLLOWING ANGIO-SEAL DEPLOYMENT AND A PRESSURE BANDAGE WAS APPLIED. THE PT WAS READMITTED TWO DAYS LATER DUE TO HEAVY BLEEDING MOST LIKELY CAUSED BY THE CORONARY ANGIOGRAPHY. SURGICAL INTERVENTION WAS PERFORMED TO CLOSE THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283138 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA 4021014

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R