BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 959752 · Received April 25, 2007

    Report

    Report Number
    2953144-2007-00535
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    July 22, 2005
    Report Date
    July 22, 2005
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. POST PTA OF THE ILIAC ARTERY, THE PHYSICIAN COULD ONLY PARTIALLY ADVANCE THE THUMB ADVANCER. THE PHYSICIAN USED THE SAFETY RELEASE BUTTON TO RELEASE THE VESSEL LOCATOR AND REMOVED THE DEVICE. THE VESSEL LOCATOR WAS STILL DEPLOYED AND PIECES OF THE METAL FROM THE TIP OF THE CLIP DELIVERY TUBE WERE STICKING OUT AT RIGHT ANGLES TO THE DEVICE. THE PHYSICIAN REVERTED TO MANUAL COMPRESSION IN COMBINATION WITH ANOTHER BRAND OF DEVICE TO ACHIEVE HEMOSTASIS. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA 25096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other