BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1040173 · Received May 8, 2008

    Report

    Report Number
    2953144-2008-00860
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MALFUNCTION: DIFFICULT TO REMOVE, VESSEL LOCATOR WINGS DID NOT RETRACT. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: ENLARGED VESSEL TRACT, OOZING. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC CARDIAC ANGIOGRAM. REPORTEDLY, AFTER DEPLOYING THE CLIP THE DEVICE WAS DIFFICULT TO REMOVE. THE VESSEL LOCATOR BUTTON WAS THROTTLED TO RELEASE THE VESSEL LOCATOR WINGS UNSUCCESSFULLY. THE VESSEL TRACT WAS WIDENED ENABLING THE DEVICE TO BE REMOVED. THE STARCLOSE CLIP ACHIEVED HEMOSTASIS. OOZING WAS NOTED; THEREFORE, MANUAL COMPRESSION WAS APPLIED PROPHYLACTICALLY FOR 10 MINUTES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention