BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1884069 · Received October 20, 2010

    Report

    Report Number
    3003681312-2010-00067
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR 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. IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL VIP WAS DEPLOYED IN THE PT'S COMMON FEMORAL ARTERIOTOMY POST PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WAS NO PERIPHERAL VASCULAR DISEASE, SCARRED OR FIBROTIC TISSUE AT THE PUNCTURE SITE. THE PT AMBULATED 2 HOURS LATER WITH NO REPORTED PROBLEMS. FOUR HOURS POST PROCEDURE, WHILE THE PT WAS RESTING IN BED, A HEMATOMA DEVELOPED. THE PT UNDERWENT SURGICAL TREATMENT FOR THE HEMATOMA, WHERE THE COLLAGEN WAS INSIDE THE FEMORAL ARTERY. THE PT WAS LATER DISCHARGED FROM THE HOSPITAL. THE PT IS REPORTED TO BE FINE. HEPARIN, 10000 UNITS AND 75 MG OF CLOPIDOGREL WERE GIVEN DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA 3100796

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 75MG OF CLOPIDOGREL POST PROCEDURE| 100 MG OF ASPIRIN POST PROCEDURE