BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2190970 · Received July 28, 2011

    Report

    Report Number
    3003681312-2011-00052
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 28, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO 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) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT IF RE-PUNCTURE AT THE SAME LOCATION OF PREVIOUS ANGIO-SEAL DEVICE IS NECESSARY IN LESS THAN OR EQUAL TO 90 DAYS, RE-ENTRY SHOULD BE ONE CENTIMETER PROXIMAL TO THE PREVIOUS ACCESS SITE.

    Description of Event or Problem · 1

    A 6F VIP ANGIO-SEAL DEVICE WAS DEPLOYED IN THE LEFT FEMORAL ARTERY FOLLOWING A DIAGNOSTIC PROCEDURE AND A PRE-INSERTION ANGIOGRAM. THERE WAS A LITTLE BLEEDING AFTER THE PROCEDURE. THE SAME ARTERY ACCESSED IN THIS PROCEDURE HAD BEEN ACCESSED LESS THAN THIRTY DAYS AGO. LATER, THE PT DEVELOPED LEG PAIN AND THE LEG WAS COLD. AN ANGIOGRAM REVEALED THAT THE PT HAS A VESSEL OCCLUSION IN THE BIFURCATION OF THE LEFT LEG. SURGERY WAS PERFORMED TO REMOVE THE ANCHOR AND THE COLLAGEN FROM THE ARTERY. THE PT'S HOSPITALIZATION WAS EXTENDED, BUT THE PT IS RECOVERING AND HER LEG IS NOT WARM WITH NO PAIN.

    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 3250957

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R