BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851431 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02157
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    April 22, 2009
    Report Date
    May 4, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE LOCATOR WINGS WERE BENT AND TWO WERE DETACHED FROM THE DISTAL RETAINING RING. THE TWO BROKEN WINGS REMAINED SECURE WITHIN THE VESSEL LOCATOR. INTERNAL INSPECTION CONFIRMED THE ACCESS PORTS HAD BEEN UTILIZED TO FACILITATE DEVICE REMOVAL. THERE WERE CLIP TINE MARKS OBSERVED ON THE CARRIER TUBE, INDICATING THE CLIP WAS FIRED. BASED ON THE INVESTIGATION FINDINGS, THE LOCATOR WINGS WERE BENT PREVENTING THEM FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. BECAUSE THE WINGS WERE BENT, REMOVING THE DEVICE FROM THE PT'S ARTERY WOULD BE DIFFICULT AS REPORTED. THE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS TISSUE COMPACTION DURING THE THUMB ADVANCER DEPLOYMENT CAUSING THE WINGS TO BREAK DURING ASSERTIVE PULL. THE TWO BROKEN WINGS WERE CONSISTENT WITH THE REPORTED POST-PROCEDURE MANIPULATION RATHER THAT A DEVICE FAILURE. NO MFR 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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO FACILITATE DEVICE REMOVAL FROM THE PT'S ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. AFTER THE ARTERIOTOMY CLOSURE THE CARDIAC CATHETERIZATION LAB TECH WAS MANIPULATING THE DEVICE AND PUSHED THE LOCATOR BUTTON AND NOTED THAT TWO OF THE VESSEL LOCATOR WINGS WERE BROKEN BUT ATTACHED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION 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 73030-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention