BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3140896 · Received May 24, 2013

    Report

    Report Number
    3003681312-2013-00032
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    November 22, 2012
    Report Date
    April 25, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE EXACT LOT NUMBER WAS UNAVAILABLE. HOWEVER, THE HOSPITAL DID PROVIDE A POSSIBLE LOT NUMBER: 3839712 (MANUF: 10/01/2012; EXP: 09/30/2013). REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, 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

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AND DEPLOYED. SEVENTY-TWO HOURS POST-DISCHARGE, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH A HEMATOMA. THE PATIENT WAS LISTED AS OKAY FOLLOWING THE EVENT. ADDITIONAL INFORMATION WAS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232367 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization