BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851494 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02106
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    February 9, 2009
    Report Date
    February 11, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS REMOVED WITH THE VESSEL LOCATOR WINGS OPEN AND THE PLUNGER WAS STILL ENGAGED WITH THE SAFETY RELEASE. THE THUMB ADVANCER HAD BEEN RETRACTED TO .5 CM PROXIMAL OF THE FINISH WINDOW. THESE FINDINGS ARE CONSISTENT WITH THE REPORTED EXPERIENCE. THE PROCEDURE OF USING THE ACCESS PORTS TO REMOVE THE DEVICE WAS CONSISTENT WITH THE STARCLOSE SE INSTRUCTIONS FOR USE (IFU); HOWEVER, THE IFU ALSO INSTRUCTS THE USER TO SLIDE THE SAFETY RELEASE TO COLLAPSE THE LOCATOR WINGS. BASED ON THE POSITION OF THE PLUNGER AND SAFETY RELEASE BUTTON THIS STEP WAS NOT COMPLETED. THE FLEX-GUIDE HAD BEEN CARVED BY BENT GARAGE LEAVES, AND THE DAMAGED GARAGE LEAVES SUBSEQUENTLY CUT INTO THE EXCHANGE SHEATH. DURING THE INTERNAL OBSERVATIONS, IT WAS NOTED THAT THE CATCH, TRIGGER PIN, AND PUSHER WERE STILL IN THE PRE-CLIP DEPLOYMENT POSITIONS. THE CLIP HAD NOT BEEN DEPLOYED. THE TRIGGER PIN GUARD AND BUTTON WERE DAMAGED. THE DAMAGED TRIGGER COMPONENTS INDICATE, AND ATTEMPT WAS MADE TO DEPLOY THE CLIP PRIOR TO THE THUMB ADVANCER BEING ALIGNED IN THE FINISH WINDOW. FLEX-GUIDE CARVING OCCURS DURING THUMB ADVANCEMENT WHEN THE TUBESET IS NOT KEPT IN LINE, THE FLEX-GUIDE, CAUSING THE TUBES TO STRIKE THE FLEX-GUIDE, FLARING THE GARAGE LEAVES, WHICH CUT INTO THE EXCHANGE SHEATH. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE FLEX-GUIDE CARVING AND RESULTING EXCHANGE SHEATH DAMAGE WAS A MISALIGNMENT OF THE TUBESET IN RELATION TO THE FLEX-GUIDE. THE ROOT CAUSE FOR THE TRIGGER BUTTON AND TRIGGER PIN GUARD DAMAGE IS AN ATTEMPT TO FIRE THE CLIP PRIOR TO FULL THUMB ADVANCEMENT. IT IS POSSIBLE THAT THE CARVING AND EXCHANGE SHEATH DAMAGE PREVENTED THE THUMB ADVANCER FROM REACHING ITS FULLY DISTAL POSITION. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE HISTORY RECORD FOR THIS DEVICE 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 CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT ANATOMY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED SUCCESSFULLY TO REMOVE THE STARCLOSE SE DEVICE. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. ONCE THE DEVICE WAS REMOVED FROM THE ANATOMY, IT WAS NOTICED THAT THE #2 ON THE PLUNGER WAS STILL ENGAGED. THERE WERE NO REPORT ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 71030-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention