BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL VIP PLATFORM VASCULAR CLOSURE DEVICE

    MDR report key: 2142242 · Received June 23, 2011

    Report

    Report Number
    2142242
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    CATH LAB STAFF UTILIZING ANGIOSEAL VIP VASCULAR CLOSURE DEVICE ON PATIENT UNDERGOING PROCEDURE IN CATH LAB. WHEN THE TIME CAME TO PULL ON THE ANGIOSEAL AND PUSH DOWN ON THE TAMPER ROD, THE TAMPER ROD WAS NOT THERE. THE COLLAGEN TO BE DEPLOYED REMAINED ON THE OUTSIDE OF THE PATIENT'S BODY WITH NO TAMPER ROD AVAILABLE TO DEPLOY THE COLLAGEN. STAFF HELD PRESSURE OVER THE SHEATH ENTRY SITE, ASSESSED THE DEVICE AND PULLED A LITTLE MORE ON THE ANGIOSEAL HEAD TO SEE IF THE TAMPER ROD WAS STUCK IN THE CATHETER. IT WAS NOT. AT THIS TIME THE COLLAGEN SEAL WAS INSIDE THE TRACT AND HEMOSTASIS WAS OBTAINED. PRESSURE WAS HELD ON THE GROIN SITE FOR TEN MINUTES. MD WAS ADVISED, PATIENT STABLE WITH NO FURTHER COMPLICATIONS. DEVICE SAVED FOR EVALUATION PURPOSES. NO INJURY TO PATIENT, JUST ADDITIONAL TIME TROUBLESHOOTING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VIP PLATFORM VASCULAR CLOSURE DEVICE ANGIOSEAL VIP PLATFORM VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL 610130 3313278

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR