BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1970658 · Received January 25, 2011

    Report

    Report Number
    2024168-2011-00452
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 31, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS PARTIALLY DEPLOYED AND THE CLIP VISIBLE AND STILL LOADED ON THE CARRIER TUBE. IT WAS ADDITIONALLY REPORTED THAT RESISTANCE WAS FELT DURING THUMB ADVANCER DEPLOYMENT WHICH WAS STOPPED APPROXIMATELY 1-2MM DISTAL OF THE TIP. AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU), THE SAFETY RELEASE MECHANISM WAS ACTIVATED TO FACILITATE REMOVAL OF THE DEVICE FROM THE PATIENT ANATOMY. INTERNAL INSPECTION FOUND THE MOVEMENT OF AN INTERNAL COMPONENT (GARAGE BLOCK) WAS RESTRICTED WHICH RESULTED IN THE PROXIMAL DISPLACEMENT OF THE COMPONENTS TUBE AND EXPOSURE OF THE LOADED CLIP. THIS PREVENTED FURTHER DEPLOYMENT OF THE DEVICE AND THE CLIP BY LIMITING THE MOVEMENT OF THE CLIP PUSHER BLOCK/TUBE ASSEMBLY. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE ROOT CAUSE FOR THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK AND SUBSEQUENT INABILITY TO DEPLOY THE CLIP IS DUE TO RESISTANCE ENCOUNTERED WHILE ADVANCING THE THUMB ADVANCER. RESISTANCE ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT IS CONSISTENT WITH RADIAL FORCE CONSTRICTION ON THE SHEATH. FACTORS THAT MAY CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS. THE INVESTIGATION IS ON-GOING. ADDITIONALLY, 7 UNUSED REPRESENTATIVE SAMPLES WITH THE SAME PART AND LOT NUMBER WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON ALL OF THE RETURNED DEVICES AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING ISSUES OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. 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.

    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 A RIGHT COMMON FEMORAL AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT DURING THUMB ADVANCEMENT. THE CLIP DELIVERY TUBE NEVER ENTERED THE TISSUE TRACT DUE TO THE THUMB ADVANCER FAILING TO COMPLETELY SPLIT THE SHEATH. THE VESSEL LOCATOR WINGS PROLASPED AND THE DEVICE CAME OUT OF THE PATIENT. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS 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 920316H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention