BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1050249 · Received May 21, 2008

    Report

    Report Number
    3003681312-2008-00055
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE 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 INSTRUCT 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 THE PT PRESENTED TO HOSPITAL EMERGENCY ROOM WITH CHEST PAIN. THE NEXT MORNING, THE PT WENT TO THE CATH LAB FOR EVALUATION. THE PT'S OPENING PRESSURE WAS 210/102. A STENT WAS PLACED FOR A 95% LEFT ANTERIOR DESCENDING CORONARY ARTERY LESION. A FEMORAL ANGIOGRAM WAS PERFORMED AND AN ANGIO-SEAL WAS DEPLOYED; HEMOSTASIS WAS ACHIEVED. THE PT'S BLOOD PRESSURE AT THE TIME OF ANGIO-SEAL DEPLOYMENT WAS 219/118. DURING THE PROCEDURE, 6000 UNITS OF UNFRACTIONATED HEPARIN (UFH) AND 2-9ML BOLUSES OF INTEGRILIN WERE ADMINISTERED TO THE PT AND A 16ML/HR DRIP OF INTEGRILIN WAS STARTED. PRESSURE WAS HELD ON THE GROIN FOR 5 MINUTES PER THE CATH LAB PROTOCOL. DURING THIS TIME, THE PT COMPLAINED OF INTENSE PAIN IN THE RIGHT GROIN. AFTER THE DRESSING WAS APPLIED TO THE GROIN AND THE DRAPE WAS REMOVED, A LARGE HEMATOMA WAS NOTICED EXTENDING WELL ABOVE THE PUNCTURE SITE. THE INTEGRILIN WAS DISCONTINUED. THE PHYSICIAN THEN ACCESSED THE LEFT GROIN. A VIABAHN COVERED STENT WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC ARTERY. SEVEN DAYS LATER, THE PT WAS REPORTED AS STABLE, BUT STILL HOSPITALIZED. THE PHYSICIAN DESCRIBED HIS FINDINGS OF THIS INCIDENT AS A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2056295

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R