BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1023189 · Received March 24, 2008

    Report

    Report Number
    3003681312-2008-00029
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 10, 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
    TX, US
    Reporter Occupation
    RISK MANAGER

    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 INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL IFU CAUTIONS THE USE OF THE ANGIO-SEAL IN PEDIATRIC PATIENTS OR OTHERS WITH SMALL FEMORAL ARTERY SIZE (<4MM IN DIAMETER). SMALL FEMORAL ARTERY SIZE MAY PREVENT THE ANGIO-SEAL ANCHOR FROM DEPLOYING PROPERLY IN THESE PTS.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A HEART CATHETERIZATION PROCEDURE, A 6F ANGIO-SEAL VIP WAS USED ON THE RIGHT FEMORAL ARTERIOTOMY. THE PRE-DEPLOYMENT FEMORAL ANGIOGRAM REVEALED THE FEMORAL ARTERY DIAMETER TO BE LESS THAN 4 MILLIMETERS IN CIRCUMFERENCE. APPROXIMATELY ONE HOUR LATER, THE PT COMPLAINED OF RIGHT LEG PAIN. THE PULSES TO THE RIGHT LEG WERE COMPROMISED. THE PATIENT UNDERWENT SURGICAL INTERVENTION. THE ANGIO-SEAL WAS REMOVED. THE PT WAS NOT TAKING PRESCRIBED ANTI-COAGULANTS.

    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 2042400

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention