BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE

    MDR report key: 4222292 · Received November 3, 2014

    Report

    Report Number
    2182269-2014-00044
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    PP930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, 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 INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL EVOLUTION WAS DEPLOYED AND THE PATIENT WAS SENT TO RECOVERY. IT WAS REPORTED THE PATIENT WAS STILL BLEEDING TWO HOURS POST-PROCEDURE. IT WAS ASSESSED AS A FAILED CLOSURE. PULSES WERE NOT DIMINISHED AND A SECOND 6F ANGIO-SEAL EVOLUTION WAS DEPLOYED. PULSES DIMINISHED AND THE PATIENT EXPERIENCED A COLD LEG, REQUIRING A SURGICAL CUT DOWN AND REPAIR OF THE OCCLUDED VESSEL. THE PATIENT WAS STABLE WITH NO GROIN COMPLICATIONS FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702965 ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL C610134

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ANGIO-SEAL EVOLUTION (MODEL: 610134)