BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2003383 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01260
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CLIP WAS NOT FIRED. 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, RESULTING IN BENT GARAGE LEAVES THAT PUNCTURED AND TORE THE SHEATH. THE SAFETY RELEASE MECHANISM WAS UTILIZED TO COLLAPSE THE LOCATOR WINGS TO SAFELY REMOVE THE DEVICE FROM THE PATIENTS BODY AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). THE PROBABLE ROOT CAUSE FOR THE FLEX-GUIDE CARVING 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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO INCIDENTS WITH SIMILAR REPORTED PRODUCT EXPERIENCE. ALSO, THERE WERE NO SIMILAR INCIDENTS THAT EXHIBITED THE FLEX-GUIDE CARVING AT THE PROXIMAL END WHEN DEPRESSING THE PLUNGER TO INITIATE THUMB ADVANCER DEPLOYMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "THE SHEATH SPLIT AT A DIFFERENT STEP", THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. A FEMORAL ANGIOGRAM WAS NOT TAKEN PRIOR TO THE PROCEDURE. 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 910336H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention