BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 813276 · Received January 12, 2007

    Report

    Report Number
    2953144-2007-00024
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    January 18, 2006
    Report Date
    January 27, 2006
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT 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 WITH THE STARCLOSE VASCULAR CLOSURE. THE PHYSICIAN FIRED THE CLIP AND THE DEVICE GOT STUCK AND HE COULD NOT REMOVE IT EASILY. REPORTEDLY, WITH SOME MANIPULATION TO PRESS THE VESSEL LOCATOR BUTTON MANY TIMES AND SOME TWISTING, THE PHYSICIAN PULLED OUT THE DEVICE. THE CLIP REMAINED IN THE PATIENT AND HEMOSTASIS WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM FZP ABBOTT VASCULAR INC. NA 24075-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 YR