BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1080481 · Received July 21, 2008

    Report

    Report Number
    3003681312-2008-00068
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE IFU ALSO STATES FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A HEART CATHETERIZATION AND RIGHT CORONARY ARTERY INTERVENTION, A POST PROCEDURE ANGIOGRAM WAS PERFORMED; THE PUNCTURE SIGHT LOOKED GOOD FOR ANGIO-SEAL DEPLOYMENT. THERE WAS SOME MINIMAL PLAQUE NOTED BELOW THE PUNCTURE SITE. THE 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY. AFTER PULLING THE TAMPER TUBE OUT, BLEEDING OCCURRED. OCCLUSIVE PRESSURE WAS PERFORMED AND HEMOSTASIS WAS OBTAINED. PULSES WHERE CHECKED AND WERE DIMINISHED IN THE RIGHT LOWER EXTREMETY. A 4F SHEATH WAS PLACED IN THE LEFT GROIN AND AN ANGIOGRAM WAS PERFORMED. BLOOD FLOW WAS SLOW AT THE POINT OF ANGIO-SEAL DEPLOYMENT AND LUCENCY WAS NOTED. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE SURGEON PERFORMED A CUT DOWN OF THE ARTERY AND REMOVED THE ANGIO-SEAL FROM INSIDE THE ARTERY (COLLAGEN AND THE ANCHOR). BOTH WERE SENT TO PATHOLOGY. THE PATIENT CUTDOWN SITE WAS CLOSED AND THE PATIENT WAS GIVEN 1 GRAM OF ANCEF. PULSES WERE BACK TO PRE-PROCEDURE STATUS AND THE PATIENT IS DOING WELL.

    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 PUERTO RICO, B.V. NA 2076405

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention