BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2083583 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03361
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE DEVICE FOUND IT WAS RETURNED PARTIALLY DEPLOYED WITHOUT HAVING THE CLIP-FIRING (TRIGGER BUTTON) ACTIVATED. THE THUMB ADVANCER STROKE AND SHEATH SLIT WERE NOT COMPLETE. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE PROXIMAL END OF THE FLEX-GUIDE WAS HEAVILY CARVED BY THE DELIVERY TUBESET WHEN DEPRESSING THE PLUNGER TO DEPLOY THE LOCATOR WINGS AND INITIATE THE THUMB ADVANCER DEPLOYMENT, RESULTING IN BENT GARAGE LEAVES THAT PUNCTURED AND TORE THE SHEATH AND FLEX-GUIDE. SUBSEQUENTLY, THE THUMB ADVANCER DEPLOYMENT AND SHEATH SPLITTING WERE STOPPED DUE TO EXCESSIVE RESISTANCE ENCOUNTERED AS REPORTED. BECAUSE THE THUMB ADVANCER STROKE COULD NOT BE COMPLETED, ALTHOUGH THE TRIGGER BUTTON WAS REPORTED AS BEING DEPRESSED, THE CLIP COULD NOT BE FIRED. THE SAFETY RELEASE MECHANISM WAS ACTIVATED TO COLLAPSE THE LOCATOR WINGS TO REMOVE THE DEVICE, THE SAFETY RELEASE BUTTON WAS DISLOCATED. BASED ON THE INVESTIGATION, THE PROBABLE CAUSE FOR THE FLEX-GUIDE CARVING AND SUBSEQUENT FAILURE TO COMPLETE THE THUMB ADVANCER STROKE 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. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (DATE OF EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED TWO WEEKS FROM THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS ESTIMATED DATE. 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 PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THUMB ADVANCEMENT FRICTION WAS EXPERIENCED, HOWEVER SHEATH SPLITTING WAS COMPLETED AND THE CLIP WAS FIRED. THE DEVICE BECAME STUCK AND THE PHYSICIAN USED THE SAFETY FEATURES TO REMOVE THE DEVICE FROM THE PATIENT'S GROIN. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION INDICATES; EXCESSIVE RESISTANCE WAS ENCOUNTERED WHILE DEPLOYING THE THUMB ADVANCER. THE PHYSICIAN DEPRESSED THE TRIGGER BUTTON TO FIRE THE CLIP, BUT WAS UNAWARE IF THE CLIP WAS DEPLOYED IN THE PATIENT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 960076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention