BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851356 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02197
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 7, 2009
    Report Date
    July 7, 2009
    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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE LOCATOR WINGS WERE BENT, PREVENTING THEM FROM FULLY COLLAPSING INTO THE DELIVERY TUBE SET WHEN THE CLIP WAS FIRED, RESULTING IN DIFFICULT DEVICE REMOVAL. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS TISSUE COMPACTION DURING THUMB ADVANCER DEPLOYMENT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBE SET AND THE LOCATOR WINGS CAN BEND THE WINGS AND CAUSE DIFFICULTY IN REMOVING THE DEVICE AFTER USE. NO MANUFACTURING OR QUALITY 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 A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE THE ACCESS PORTS WERE USED AND THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 74055-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention