BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1832148 · Received September 3, 2010

    Report

    Report Number
    2953144-2010-01868
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY, DIFFICULT TO REMOVE. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TECH TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT DIFFICULTY WAS ENCOUNTERED HALFWAY THROUGH DEPLOYMENT. ADDITIONAL PRESSURE WAS APPLIED ENABLING COMPLETION OF THE THUMB ADVANCER DEPLOYMENT. AFTER DEPLOYING THE CLIP, RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL. A DILATOR WAS INSERTED INTO THE ACCESS PORTS WHICH RELEASED THE DEVICE FROM THE PT ANATOMY. WHEN THE DEVICE WAS REMOVED, HEMOSTASIS WAS ACHIEVED, AND THE CLIP WAS DEPLOYED IN THE INTENDED LOCATION IN THE VESSEL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1