BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 959810 · Received April 25, 2007

    Report

    Report Number
    2953144-2007-00536
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    June 26, 2005
    Report Date
    June 27, 2005
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 REPORTABLILITY. 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. THE THUMB ADVANCER COULD NOT BE PUSHED TO ITS FINAL POSITION BEFORE CLIP DEPLOYMENT. THE PHYSICIAN PRESSED THE SAFETY RELEASE BUTTON AND THE VESSEL LOCATOR WINGS DID NOT RETRACT. THE DEVICE WAS REMOVED FROM THE PT WITH THE VESSEL LOCATER WINGS DEPLOYED. IT WAS OBSERVED THAT THE CLIP WAS BENT AND PLASTIC FROM THE INNER SHEATH WAS IN A LUMP TOWARDS THE TIP OF THE DEVICE. THE PHYSICIAN REVERTED TO MANUAL COMPRESSION 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 25026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other