BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1904796 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02886
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLEX GUIDE WAS SLIGHTLY BENT AND THE SLIT ON THE SHEATH STOPPED APPROXIMATELY A 1/2 INCH FROM THE DISTAL END AND THE THUMB ADVANCER WAS APPROXIMATELY 3/4 OF AN INCH TO THE FINISH POSITION/WINDOW. INTERNAL EXAMINATION OF THE DEVICE FOUND THAT THE CATCH WAS STILL IN THE PRE-DEPLOYED POSITION. THE GARAGE TUBE ASSEMBLY WAS NORMAL AND THE CLIP WAS STILL LOADED. THERE WAS SHAFT CARVING NOTED ON THE FLEX GUIDE APPROXIMATELY A 1/2 INCH FROM THE PROXIMAL RETAINING RING. THE MOST PROBABLE ROOT CAUSE FOR DISTAL END FLEX-GUIDE CARVING IS A FAILURE TO MAINTAIN ALIGNMENT BETWEEN THE TUBESET AND FLEX-GUIDE THROUGHOUT THE THUMB ADVANCER STROKE, CAUSING THE TUBESET TO CARVE INTO THE FLEX-GUID, AND SUBSEQUENTLY, PREVENTING COMPLETION OF THE THUMB ADVANCER STROKE AND SHEATH SLITTING. NO MANUFACTURING OR QUALITY ISSUE WAS 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

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "THE METAL SHAFT BENT" RESULTING IN THE CLIP NOT DEPLOYING. THE DEVICE WAS REMOVED UNEVENTFULLY AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) SHAFT SEPARATED PROXIMALLY, JUST PAST THE HUB, DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHICH HAD A SEVERE BEND. AFTER THE USE OF A NON-ABBOTT GUIDE CATHETER AND PRE-DILATATION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE PROMUS RX 12 X 3.0 MM STENT BUT COULD NOT DUE TO THE TORTUOUSITY OF THE VESSEL. THE STENT WAS ABOUT TO BE DEPLOYED; HOWEVER, THE SHAFT OF THE SDS BROKE. ATTEMPTS TO REMOVE THE SDS RESULTED IN THE STENT DISLODGING FROM THE BALLOON. USING A NON-ABBOTT BALLOON CATHETER, THEY WERE ABLE TO CAPTURE AND SUCCESSFULLY DEPLOY THE PROMUS RX STENT JUST DISTAL TO THE TARGET LESION WITH GOOD RESULTS. ANGIOPLASTY WAS PERFORMED ON THE MID LAD DUE TO THE INABILITY TO PASS ANOTHER STENT. NO PATIENT EFFECTS WERE NOTED AND NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 910336H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention