BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 960102 · Received April 25, 2007

    Report

    Report Number
    2953144-2007-00425
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    September 22, 2005
    Report Date
    September 22, 2005
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 AFTER AN INTERVENTIONAL PROCEDURE. THE PHYSICIAN SUCCESSFULLY DEPLOYED THE STARCLOSE CLIP AND HEMOSTASIS WAS ACHIEVED AFTER ONE MIN OF MANUAL COMPRESSION. THE PHYSICIAN ATTEMPTED TO REMOVE THE STARCLOSE DEVICE WITH ONE FINGER ON EACH SIDE OF THE DEVICE WITH PRESSURE DOWNWARDS ON THE ARTERY AND PULLING STRAIGHT OUT. THE SAFETY RELEASE BUTTON WAS ACTIVATED. THE PHYSICIAN OBSERVED THAT THE WINGS WERE BROKEN AND NOT IN THEIR ORIGINAL SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA 31003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other