BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1260051 · Received December 10, 2008

    Report

    Report Number
    2953144-2008-01995
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA`
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNABLE TO ATTACH SHEATH TO CLIP APPLIER. TIME OF MALFUNCTION: DURING DEVICE INSERTION. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN ATTACHING THE CLIP APPLIER TO THE SHEATH, THEY DID NOT CLICK TOGETHER. THE DEVICE AND SHEATH WERE REMOVED. A SECOND SHEATH AND STARCLOSE. SE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PT EFFECTS. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention