BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851708 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02331
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    February 1, 2009
    Report Date
    February 3, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FULLY CLIP DEPLOYED WITHOUT THE DEPLOYED CLIP. THE THUMB ADVANCER AND CLIP DELIVERY TUBESET WERE RETRACTED PROXIMALLY CONSISTENT WITH THE SUCCESSFUL USE OF THE DILATOR ASSISTED ACCESS PORTS. THE DILATOR ASSISTED ACCESS PORTS WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE TO RETRACT THE THUMB ADVANCER AND CLIP DELIVERY TUBESET, WHICH ARE DESIGNED TO ENABLE THE OPERATOR EASIER DEVICE REMOVAL IN THE EVENT DIFFICULTY IS ENCOUNTERED DURING DEVICE REMOVAL. IT WAS DETERMINED THE DILATOR ASSISTED ACCESS PORTS FUNCTIONED AS DESIGNED. THE SAFETY RELEASE WAS DISPLACED, WHICH IS CONSISTENT WITH AN ERROR IN THE OPERATOR'S TECHNIQUE BECAUSE THE SAFETY RELEASE IS OPERATIONAL ONLY PRIOR TO CLIP DEPLOYMENT AND IS INACCESSIBLE AND INOPERATIVE FOR NORMAL MANIPULATION AFTER CLIP DEPLOYMENT. THE APPLICATION OF DOWNWARD FORCE APPLIED TO THE SAFETY RELEASE DISPLACES IT INTO THE HANDLE CAVITY FROM ITS SECURING HANDLE FEATURES. THE DEVICE WAS RETURNED WITH BENT LOCATOR WINGS; HOWEVER, IT WAS DETERMINED THAT ALL OF THE LOCATOR WING MATERIAL REMAINED SECURE WITHIN THE VESSEL LOCATOR ASSEMBLY. BENT LOCATOR WINGS ARE CONSISTENT WITH A DEVICE THAT IS DIFFICULT TO REMOVE. THE PROBABLE, THOUGH UNCONFIRMED ROOT CAUSE FOR THE BENT LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BELOW THE DISTAL END OF THE TUBESET AND LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT WHICH MAY CREATE DISTAL FORCES RESULTING IN BENDING OF THE LOCATOR WINGS AND SUBSEQUENTLY CONTRIBUTING TO DIFFICULTY REMOVING THE DEVICE. THE ROOT CAUSE FOR THE DISPLACED SAFETY RELEASE WAS RELATED TO THE IMPROPER TECHNIQUE OF THE OPERATOR. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    THE STARCLOSE SE DEVICE WAS RECEIVED WITH ANOTHER STARCLOSE SE FROM THE CUSTOMER WITH NO INFORMATION PROVIDED. ALTHOUGH, THE EVALUATION OF THE RETURNED DEVICE FOUND THAT THE COMPONENTS WERE IN THE CLIP-DEPLOYED POSITIONS, IT WAS NOT SPECIFIED IF HEMOSTASIS WAS AFFECTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ATTEMPTS TO OBTAIN INFORMATION FROM THE USER FACILITY WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 64036-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention