BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3190138 · Received June 21, 2013

    Report

    Report Number
    2182269-2013-00051
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 SERIAL NUMBER WAS UNAVAILABLE. 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. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATS: SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED THE PT, WHO WAS STATUS FOUR DAYS POST HEART CATHETERIZATION FOR AN ACUTE MI, HAD AN AORTOGRAM WITH RUNOFF PERFORMED TO ACCESS THE BLOOD FLOW IN THE ISCHEMIC RIGHT LOWER EXTREMITY. A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE LEFT COMMON FEMORAL ARTERIOTOMY. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 20 MINUTES TO ACHIEVE HEMOSTASIS. LATER THAT EVENING, THE PT HAD DIMINISHED PULSES IN THE LEFT LOWER EXTREMITY AND UNDERWENT SURGICAL INTERVENTION. THE SURGEON INDICATED THE ANGIO-SEAL ANCHOR AND SOME SUTURE WERE RETRIEVED WITH THE USE OF THE FOGARTY THROMBECTOMY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283600 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R