BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 844239 · Received April 25, 2007

    Report

    Report Number
    2953144-2007-00436
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    November 30, 2005
    Report Date
    December 5, 2005
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, DEVICE MALFUNCTION COULD NOT BE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS THAT ATTRIBUTED TO THIS INCIDENT. WE HAVE IDENTIFIED A COMPLAINT THAT HAS MET THE CRITERIA FOR REPORTABILITY. SUBSEQUENTLY, WE HAVE DETERMINED THAT THIS EVENT IS REPORTABLE AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED AN ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE. AS THE THUMB ADVANCER REACHED ABOUT 2CM FROM THE ENGAGEMENT ARROW, IT BECAME IMPOSSIBLE TO ADVANCE. THE PHYSICIAN OBSERVED BLEEDING AROUND THE DEVICE AND A HEMATOMA BEGINNING TO FORM. THE PHYSICIAN DID NOT USE THE SAFETY RELEASE BUTTON. THE PHYSICIAN SPLIT THE SKIN AND REMOVED THE DEVICE WITH THE NITINOL WINGS OPEN. THE PHYSICIAN REVERTED TO MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PT EXPERIENCED A HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA 28020

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other 5000 U HEPARIN