BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 2971477 · Received February 6, 2013

    Report

    Report Number
    2971477
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A SIMILAR OCCURRENCE WAS PREVIOUSLY REPORTED TO MEDSUN. TWO MORE EPISODES WITH SAME DEVICES ARE REPORTED BELOW.1. DEVICE WAS DEPLOYED ACCORDING TO MANUFACTURER DIRECTIONS, HOWEVER, THE TAMP-TUBE DID NOT DEPLOY DOWNWARD AUTOMATICALLY AS IT SHOULD, TO TAMP THE COLLAGEN TO ARTERIOTOMY. TECH HAD TO "FILET" THE SHEATH TUBE BACK TO EXPOSE THE TAMP-TUBE, AND MANUALLY SLIDE AND TAMP COLLAGEN. TECH WAS ABLE TO AID THE DEVICE TO DEPLOY PROPERLY AS BEFORE.2. UPON USING THE ARTERIAL CLOSURE DEVICE AS PER MANUFACTURER PROTOCOL, THE TAMP TUBE DID NOT DEPLOY AT THE CORRECT TENSION. TECH HAD TO "FILET" THE DELIVERY SHEATH OF DEVICE BACK IN ORDER TO MANUALLY (WITH A HEMOSTAT) PULL DOWN THE TAMP TUBE TO PUSH THE COLLAGEN ONTO THE ARTERIOTOMY. HAVING HAD (AT THIS COUNT) 3 INCIDENCES WITH THE DEVICE NOT DEPLOYING PROPERLY, TECH KNEW WHAT TO DO TO SALVAGE THE DEVICE AND PREVENT HARM TO PATIENT WHO WAS ANTICOAGULATED FOR THE PROCEDURE. TECH WAS ABLE TO SECURE THE PUNCTURE SITE AND NO BLEEDING WAS SEEN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VASCULAR CLOSURE POST HEART CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51204 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB ST JUDE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *