BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2090393 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03505
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INVESTIGATION OF THE RETURNED DEVICE FOUND THE FLEX-GUIDE HAD BEEN CARVED BY THE SUPPORT TUBE DURING THUMB ADVANCEMENT. THE PLUNGER WAS ENGAGED DEPLOYING THE VESSEL LOCATOR IN THE OPENED POSITION. THUMB ADVANCEMENT AND SHEATH SLITTING HAD BEEN STOPPED AT THE POINT OF THE CARVING. BASE ON THESE FINDING THE REPORTED EXPERIENCE IS CONFIRMED. THE CAUSE FOR THIS TYPE OF DAMAGE IS DUE TO THE FLEX-GUIDE, TUBE SET, AND TISSUE TRACT NOT BEING CORRECTLY ALIGNED DURING THUMB ADVANCEMENT AND/OR DEPLOYING THE DEVICE IN A CHALLENGING ANATOMY. THE MISALIGNMENT CAUSES THE SUPPORT TUBE TO STRIKE THE FLEX-GUIDE AND STOP, LEAVING THE GARAGE LEAVES UNSUPPORTED, STRIKING AND CARVING INTO THE FLEX-GUIDE DURING THUMB ADVANCEMENT. SUBSEQUENTLY, THE COMPLETION OF THE THUMB ADVANCER STROKE AND SHEATH SLITTING WAS PREVENTED. WHEN THE DOWNWARD DEPLOYMENT OF THE THUMB ADVANCER WAS STOPPED, THE UNSTABLE DEVICE MAY BE PULLED OUT OF THE ACCESS SITE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THERE WAS NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE FOR THE SHAFT CARVING AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS DUE TO INCORRECT TECHNIQUE DURING THUMB ADVANCEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR PRODUCT QUALITY DEFICIENCY.

    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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHILE ADVANCING THE THUMB ADVANCER SLIGHT RESISTANCE WAS FELT AND THE DEVICE "JUMPED" BACKWARDS SLIGHTLY AND CAME OUT OF THE ARTERY WITH THE LOCATOR WINGS IN THE OPEN POSITION. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 950396H

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention