BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851787 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02218
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 2, 2009
    Report Date
    December 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT IT WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER HAD BEEN UNLOCKED AFTER CLIP DEPLOYMENT AND RETRACTED PROXIMALLY. THE EXCHANGE SHEATH, TUBE SET, SAFETY RELEASE BUTTON AND PLUNGER WERE IN THE CORRECT POST DEPLOYMENT POSITIONS AND UNDAMAGED. THE VESSEL LOCATOR WINGS WERE BENT AND BROKEN AT THE DISTAL RETAINING RING, HOWEVER, STILL ATTACHED TO THE DEVICE AT THE PROXIMAL RETAINING RING AND PUSHER BODY BONDS. ALL OF THE COMPONENTS OF THE VESSEL LOCATOR ASSEMBLY WERE RETURNED. NO OTHER DAMAGE OR ABNORMALITIES WERE DETECTED. DURING CLIP DEPLOYMENT THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, THE VESSEL LOCATOR WINGS OF THIS DEVICE WERE BENT AND BROKEN. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BENT AND BROKEN LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBE SET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES RESULTING IN BENDING OF THE LOCATOR WINGS AND SUBSEQUENT DIFFICULTY WITH DEVICE REMOVAL. 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 INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE FROM THE PT'S ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. NO ADVERSE PT EFFECTS WERE REPORTED. 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 80028-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention