BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851524 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02090
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 5, 2009
    Report Date
    January 5, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. EXTERNAL EXAMINATION FOUND THE THUMB ADVANCER ALIGNED IN THE FINISH WINDOW AND IN THE LOCKED POSITION. THIS IS INCONSISTENT WITH THE REPORTED EVENT. THE SAFETY RELEASE BUTTON WAS FOUND PUSHED INWARD AND NOT VISIBLE AT THE WINDOW. THE DEVICE WAS OPENED AND THE SAFETY RELEASE ROD WAS FOUND PUSHED INWARD OUT OF THE RETAINING TABS. THIS FINDING INDICATES THAT AN ATTEMPT WAS MADE TO USE THE SAFETY RELEASE TO REMOVE THE DEVICE PRIOR TO USING THE ACCESS PORTS TO RETRACT THE THUMB ADVANCER. AFTER THE CLIP IS FIRED, THE SAFETY RELEASE IS NO LONGER FUNCTIONAL. THE VESSEL LOCATOR WINGS WERE BENT. BENT LOCATOR WINGS INDICATE THAT COMPRESSION OF TISSUE BETWEEN THE DISTAL END OF THE TUBE SET AND THE LOCATOR WINGS CREATED HIGH DISTAL FORCES ON THE LOCATORS CAUSING THEN TO BEND. THE BENT WINGS DURING REMOVAL CAN CREATE A DIFFICULT REMOVAL CONDITION. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE BENT VESSEL LOCATOR WINGS IS RELATED TO THE OPERATIONAL CONTEXT MFG IN WHICH THE DEVICE WAS USED. THE ROOT CAUSE FOR THE MISLOCATED SAFETY RELEASE ROD IS DUE TO INCORRECT TECHNIQUE/PROCEDURE. NO MFG 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 DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS RELEASING THE LOCKING MECHANISM AND THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PT ANATOMY. THE CLIP DELIVERED AND ACHIEVED HEMOSTASIS APPROPRIATELY. 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 70058-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention