BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2040839 · Received March 23, 2011

    Report

    Report Number
    3003681312-2011-00015
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS 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) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS A BI-LATERAL PUNCTURE PROCEDURE AND TWO ANGIO-SEALS WERE USED FOR CLOSURE VIA THE LEFT AND RIGHT FEMORAL ARTERIES. THE FIRST ANGIO-SEAL DEPLOYED WELL WITH NO ISSUES NOTED. THE SECOND ANGIO-SEAL DEPLOYED, THE TAMPER TUBE BECAME STUCK IN THE SHEATH AND THE PHYSICIAN WAS UNABLE TO REMOVE THE TAMPER TUBE FROM THE SHEATH. THE ANCHOR WAS IN THE CORRECT PLACE IN THE ARTERY, BUT THE COLLAGEN WAS NOT SUBCUTANEOUS AT THE VESSEL WALL. A LARGE HEMATOMA HAD FORMED AT THE PUNCTURE SITE AND MANUAL COMPRESSION WAS APPLIED. ULTRASOUND WAS PERFORMED TO DIAGNOSE THE BLEEDING. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER ROOM IN THE HOSPITAL FOR VASCULAR SURGERY WHERE THE ANGIO-SEAL WAS REMOVED AND THE HEMATOMA WAS TREATED. THE PATIENT WAS REPORTED TO HAVE LOST APPROXIMATELY 700 ML OF BLOOD DURING THE SURGERY, BUT WAS REPORTED TO FINE AND RECOVERING POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3184963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R