BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 813323 · Received January 12, 2007

    Report

    Report Number
    2953144-2007-00028
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    May 22, 2006
    Report Date
    May 24, 2006
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FZP
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE SHOWED A PUSHER BODY TO SHAFT NYLON JOINT BOND FAILURE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INCIDENT. WE HAVE IDENTIFIED A MALFUNCTION THAT HAS MET THE CRITERIA FOR REPORTABILITY. SUBSEQUENTLY, WE HAVE DETERMINED THAT THIS EVENT IS REPORTABLE AS A "PRODUCT PROBLEM (MALFUNCTION)".

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE. THE PHYSICIAN ATTEMPTED TO DELIVER THE CLIP, BUT MET RESISTANCE. HE FIRED THE CLIP AND EXCESSIVE FORCE WAS NEEDED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM FZP ABBOTT VASCULAR INC. NA 38049-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 YR