BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851686 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02290
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 9, 2009
    Report Date
    August 10, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED THAT IT WAS CLIP DEPLOYED AND THAT THE ACCESS PORT FUNCTION HAD BEEN ACTIVATED TO FACILITATE DEVICE REMOVAL. A DISPLACED SAFETY RELEASE AND BENT LOCATOR WINGS WERE DETECTED. BENT LOCATOR WINGS ARE CONSISTENT WITH STUCK DEVICE EVENTS. A POSSIBLE CAUSE FOR THE WINGS DAMAGED CONDITION MAY HAVE BEEN THE COMPACTION OF TISSUE BETWEEN THE DEPLOYED LOCATOR WINGS AND THE DISTAL END OF THE CLIP DELIVERY TUBE AS THE DELIVERY TUBE IS DEPLOYED THROUGH THE TISSUE TRACT, BENDING THE WINGS DISTALLY AWAY FROM THE OPERATOR. THIS CONDITION IN ADDITION TO THE REPORTED POSSIBLE CALCIFIED ARTERIAL TISSUE CAN RESULT IN THE INABILITY OF THE LOCATOR WINGS TO RETRACT PROPERLY INTO THE CLIP DELIVERY TUBE AFTER CLIP DEPLOYMENT, REQUIRING THE USE OF THE ACCESS PORT FUNCTION AND/OR COUNTER-TRACTION AND FORCEFUL REMOVAL FROM THE PT, WHICH MAY RESULT IN BENT LOCATOR WINGS. THE DISPLACED SAFETY RELEASE INDICATED IT HAD BEEN PUSHED DOWN DISPLACING IT INTO THE HANDLE AFTER CLIP DEPLOYMENT. THE SAFETY RELEASE IS ONLY OPERATIVE PRIOR TO CLIP DEPLOYMENT AND IS NOT FUNCTIONAL AFTER CLIP DEPLOYMENT. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THIS REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT WHICH THE DEVICE WAS USED. 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 A FEMORAL ARTERY AFTER AN INTERVENTIONAL 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 REMOVE THE DEVICE FROM THE PT'S ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 77019-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention