BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851728 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02317
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 24, 2009
    Report Date
    September 25, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED AND ALL THE EXTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITIONS. INTERNAL EXAMINATION FOUND THE VESSEL LOCATOR WINGS WERE FOUND BROKEN AT THE DISTAL END OF THE RETAINING RING. THE BROKEN PARTS WERE NOT RETURNED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BROKEN LOCATOR WINGS THAT DIRECTLY RESULTED IN THE DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND AND BREAK THE WINGS AND EVENTUALLY CAUSE DIFFICULTY IN REMOVING THE DEVICE AFTER CLIP DEPLOYMENT. 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 TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY SCARRED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED WITH COUNTER-TRACTION AND ASSERTIVE PULL APPLIED TO REMOVE THE DEVICE FROM THE PT'S ANATOMY. THE CLIP ACHIEVED HEMOSTASIS. NO ADVERSE PT SEQUELA WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL 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 79048-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention