BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2000414 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01118
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT DID NOT FIRE THE CLIP AS REPORTED. INSPECTION INDICATED THAT THE PROXIMAL END OF THE FLEX-GUIDE WAS CARVED BY THE DELIVERY TUBESET WHEN DEPRESSING THE PLUNGER TO DEPLOY THE LOCATOR WINGS AND INITIATE THE THUMB ADVANCER DEPLOYMENT AND SHEATH SPLITTING. HOWEVER, AS EXCESSIVE FORCE WAS APPLIED TO CONTINUE ADVANCING THE THUMB ADVANCER TO APPROXIMATELY 1 INCH SHORT OF THE COMPLETION WINDOW, THE GARAGE LEAVES BECAME DISRUPTED AND PUNCTURED INTO THE SHEATH, RESULTING IN BENT GARAGE LEAVES AND INCOMPLETE SLIT SHEATH. EVENTUALLY, THE THUMB ADVANCER DEPLOYMENT AND SHEATH SPLITTING STOPPED. AS PER THE INSTRUCTIONS FOR USE (IFU), DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE RESISTANCE. IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. THE DEVICE WAS FOUND PULLED OUT OF THE PATIENT'S ANATOMY WITHOUT UTILIZING THE SAFETY RELEASE MECHANISM TO COLLAPSE THE LOCATOR WINGS AS INSTRUCTED IN THE IFU. PULLING OUT THE DEVICE PRIOR TO COLLAPSING THE LOCATOR WINGS WOULD BE DIFFICULT AS REPORTED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE FLEX-GUIDE CARVING THAT SUBSEQUENTLY RESULTED IN THE INCOMPLETE DEPLOYMENT OF THE THUMB ADVANCER AND SHEATH SPLITTING IS A FAILURE TO MAINTAIN ALIGNMENT BETWEEN THE TUBESET AND FLEX-GUIDE WHEN DEPRESSING THE PLUNGER TO INITIATE THE THUMB ADVANCER DEPLOYMENT, CAUSING THE TUBESET TO CARVE INTO THE FLEX-GUIDE. PER THE IFU, DURING THE DEPLOYMENT OF THE VESSEL LOCATOR WINGS AND INITIATING THE SPLITING OF THE SHEATH, THE OPERATOR IS TO STABILIZE THE DEVICE AT AN ANGLE OF THE TISSUE TRACT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, UNKNOWN IF TRAINED IN THE USE OF THE STARCLOSE SE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. ALTHOUGH THE SAFETY RELEASE AND ACCESS PORTS WERE USED TO AID IN THE REMOVAL OF THE DEVICE; IT HAD TO BE PULLED FROM THE ANATOMY. AFTER REMOVAL, IT APPEARED AS IF THE CLIP HAD NOT BEEN FIRED AND THE SPLITTER HAD BEEN PUSHED WITH A LOT OF DOWNWARD FORCE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 910256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention