BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851383 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02205
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 5, 2009
    Report Date
    July 6, 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: THE RETURNED COMPLAINT DEVICE AS RECEIVED DID NOT MATCH THE STATED EXPERIENCE. EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED WITH THE CLIP STILL LOADED ON THE CARRIER TUBE. THE THUMB ADVANCER AND DELIVERY TUBE WERE DISTALLY DEPLOYED WITH FULL SHEATH SPLITTING. THE THUMB ADVANCER WAS RETRACTED AND THE DEVICE REMOVED VIA THE USE OF THE DILATOR ACCESS PORT FUNCTION. HOWEVER, THE SAFETY RELEASE BUTTON FUNCTION HAD NOT BEEN ACTIVATED TO ALLOW THE VESSEL LOCATOR TO RETRACT PRIOR TO DEVICE REMOVAL FROM THE ANATOMY. INSPECTION OF THE INTERNAL COMPONENTS DETERMINED SHAFT CARVING HAD TAKEN PLACE DURING THE INITIAL THUMB ADVANCER AND DELIVERY TUBE DEPLOYMENT RESULTING IN A DAMAGED SHEATH AND DISTAL END OF THE CLIP DELIVERY TUBE. THE DETECTED SHAFT CARVING AND ITS RESULTING DEVICE COMPONENT DAMAGE IS CONSISTENT WITH A FAILURE TO MAINTAIN THE ALIGNMENT OF THE CLIP DELIVERY COMPONENTS WHILE THE THUMB ADVANCER IS DISTALLY DEPLOYED. THIS RESULTS IN THE DISTAL END OF THE DELIVERY TUBE CARVING INTO THE SHAFT'S OUTER NYLON MATERIAL AND EXCHANGE SHEATH, DAMAGING THE CLIP DELIVERY TUBE IN THE PROCESS. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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 USING A STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED ARTERY. REPORTEDLY, THE THUMB ADVANCER WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED, BUT THE DEVICE WAS DIFFICULT TO REMOVE. COUNTER TRACTION WAS USED TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY. AFTER REMOVAL, IT WAS NOTICED THAT THE TIP OF THE CLIP DELIVERY TUBE WAS "MANGLED". THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 77010-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention