BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842256 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01958
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, UNSPECIFIED IF TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, PRIOR TO THE START OF ARTERIOTOMY CLOSURE, A HEMATOMA HAD DEVELOPED AT THE ACCESS SITE. AFTER UNEVENTFUL CLIP DEPLOYMENT, IT WAS NOTICED THAT HEMOSTASIS WAS ACHIEVED WITH THE STARCLOSE SE CLIP, BUT TISSUE TRACT OOZING OCCURRED THAT REQUIRED FIVE MINUTES OF ADJUNCTIVE PRESSURE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 70039-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention