BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2041943 · Received March 30, 2011

    Report

    Report Number
    3003681312-2011-00016
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE COLLAGEN FRAGMENT AND SUTURE SEGMENT, CONSISTENT WITH COMPONENTS USED IN THE ANGIO-SEAL DEVICE, WERE VISUALLY INSPECTED. THE SUTURE WAS COILED AT ONE END WITH A SHORT TAIL, CONSISTENT IN APPEARANCE WITH A DISASSEMBLED KNOT. THE OPPOSITE END WAS THREADED THROUGH THE COLLAGEN FRAGMENT, ITS END STRANDS CONSISTENT WITH CUTTING. THE ANCHOR WAS NOT RETURNED. THE OVERALL DEVICE CONDITION WAS CONSISTENT WITH CUTTING THE RUNNING SUTURE IN CLOSE PROXIMITY TO THE KNOT, USER MANIPULATION OF THE ANCHOR/COLLAGEN/SUTURE ASSEMBLY, AND SUBSEQUENT KNOT DISASSEMBLY AND ANCHOR DETACHMENT. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. 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 INSTRUCTIONS FOR USE (IFU) CAUTIONS IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR PT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PHYSICIAN WAS GETTING READY TO DEPLOY THE ANGIO-SEAL IN THE RIGHT FEMORAL ARTERY PUNCTURE SITE, THE COLLAGEN AND ANCHOR CAME OUT OF THE PT. MANUAL COMPRESSION WAS APPLIED FOR FIFTEEN MINUTES AND A HEMATOMA HAD FORMED. THE PT WAS TAKING PRESCRIBED ANALGESICS (TYPE AND DOSAGE UNK). THE PT WAS KEPT IN THE HOSPITAL FOR FURTHER MONITORING AND THEIR HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT. THE PT WAS REPORTED TO BE RECOVERING.

    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 NA 3228166

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R