BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851529 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02078
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    October 17, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. ALL COMPONENTS, EXTERNAL AND INTERNAL, WERE IN THEIR PROPER POST CLIP DEPLOYED POSITIONS AND THERE WAS NO DETECTED DAMAGE OR ANOMALY. THE DEVICE WAS TESTED WITH COMPLETE DEPLOYMENT FUNCTIONS OCCURRING WITHOUT ANY DETECTED ABNORMALITIES. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO MFG OR QUALITY INSPECTION ISSUES WERE DETECTED. 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 THE TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER DEPLOYMENT OF THE CLIP, THE PLUNGER WAS DIFFICULT TO RETRACT. THE DEPLOYMENT BUTTON WAS DEPRESSED HARD RESULTING IN THE PLUNGER RELEASING AND THE VESSEL LOCATOR RETRACTING. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 64187-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention