BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1213266 · Received October 24, 2008

    Report

    Report Number
    2182269-2008-00242
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO 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. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THAT BASED ON CLINICAL EXPERIENCE, THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES, IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST LEFT HEART CATHETERIZATION, AN INJECTION OF CONTRAST WAS MADE THROUGH A 6F SHEATH TO VIEW THE PUNCTURE SITE. THE ARTERY WAS FOUND TO BE OF SOMEWHAT SMALL CALIBER, BUT THE DECISION WAS MADE TO DEPLOY A 6F ANGIO-SEAL. THE 6F ARTERIAL SHEATH IN THE LEFT COMMON FEMORAL ARTERY WAS REMOVED AND A 6F ANGIO-SEAL WAS DEPLOYED. POST DEPLOYMENT, THE PT HAD DIMINISHED PULSES IN THE DISTAL LEFT LEG. THE PT WAS TAKEN TO SURGERY FOR THROMBECTOMY, REMOVAL OF THE ANGIO-SEAL AND REPAIR OF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R