BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1213265 · Received October 24, 2008

    Report

    Report Number
    2182269-2008-00243
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ST. JUDE MEDICAL (CD-MINNETONKA)
    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) CAUTION, 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) STATE 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 AN ANGIO-SEAL WAS DEPLOYED POST LEFT HEART CATHETERIZATION. POST PROCEDURE, AN INJECTION OF CONTRAST WAS MADE THROUGH A 6F SHEATH TO VISUALIZE THE PUNCTURE SITE. THE SHEATH WAS REMOVED OVER A WIRE AND THE ANGIO-SEAL WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERY (RCFA). BEFORE THE PT WAS MOVED FROM THE TABLE IT WAS NOTED THAT THE PT HAD DIMINISHED PULSES IN THE RIGHT LOWER EXTREMITY. THE PHYSICIAN PUNCTURED THE LEFT GROIN IN ORDER TO CROSS OVER TO THE RIGHT SIDE AND VISUALIZE THE FEMORAL ARTERY. THE ARTERY WAS FOUND TO BE OCCLUDED AT THE RCFA, JUST PROXIMAL TO THE ANGIO-SEAL DEVICE. ATTEMPTS WERE MADE TO CROSS THE BLOCKAGE WITHOUT SUCCESS. THE PT WENT TO SURGERY FOR THROMBECTOMY, REMOVAL OF THE ANGIO-SEAL COMPONENTS 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 (CD-MINNETONKA) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R