BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1884736 · Received October 25, 2010

    Report

    Report Number
    2953144-2010-02586
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - (IMPROPER REMOVAL) - (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED THAT THE TISSUE PAD WAS MELTED - FILE DOES NOT MEET THE REQUIREMENTS OF A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE LOCATOR WINGS DID NOT FULLY RETRACT CAUSING DIFFICULTY REMOVING THE DEVICE. THE DEVICE WAS REMOVED WITH COUNTER-TRACTION WITH AN ASSERTIVE PULL. THE PHYSICIAN INADVERTENTLY FORGOT TO USE THE ACCESS PORTS TO UNLOCK THE THUMB ADVANCER AND CLIP DELIVERY TUBESET TO AIDE IN THE REMOVAL OF THE DEVICE, AS INDICATED IN THE INSTRUCTIONS FOR USE. BLEEDING CONTINUED WHEN THE DEVICE WAS REMOVED; MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 86011-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention