BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2132817 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04314
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 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
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A FULLY SLIT SHEATH AND A FULLY DEPLOYED THUMB ADVANCER. INTERNAL INSPECTION REVEALED A DISPLACED CATCH AND A PUSHER-TO-GARAGE BLOCK DISPLACEMENT THAT OCCURRED WHILE ADVANCING THE THUMB ADVANCER WHICH WOULD CREATE RESISTANCE TO THE THUMB ADVANCER DEPLOYMENT AND SHEATH SPLITTING. HOWEVER, THUMB ADVANCER DEPLOYMENT AND SHEATH SLIT WERE COMPLETE, INDICATING ADDITIONAL FORCE WAS APPLIED. ALTHOUGH THE CLIP-FIRING MECHANISM WAS ACTIVATED, THE PUSHER-TO-GARAGE BLOCK DISPLACEMENT PREVENTED THE PUSHER BLOCK FROM BEING FULLY DEPLOYED TO FIRE THE CLIP OFF THE CARRIER TUBE AS INTENDED, RESULTING IN A MISALIGNMENT OF THE DELIVERY TUBESET WITH THE CLIP BEING EXPOSED ON THE CARRIER TUBE AT THE DISTAL END OF THE DEVICE. DURING THE DEVICE REMOVAL, THE CLIP WAS DRAGGED OFF THE CARRIER TUBE. IT WAS REPORTED THAT HEMOSTASIS WAS ACHIEVED WITH THE CLIP WHICH COULD HAVE BEEN DUE TO THE CLIP BEING DRAGGED OFF THE CARRIER TUBE AND LANDING AT THE ACCESS SITE, CLOSING THE VESSEL DURING DEVICE REMOVAL, BUT THAT COULD NOT BE CONFIRMED. SUBSEQUENTLY, BECAUSE THE PUSHER BLOCK DID NOT DEPLOY, IT DID NOT CONNECT WITH A COMPONENT OF THE DISTAL END OF THE RELEASE ROD, TO COLLAPSE THE LOCATOR WINGS AND DISENGAGE THE PLUNGER DUE TO THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK. THE FAILURE TO COLLAPSE THE WINGS WOULD RESULT IN DIFFICULT DEVICE REMOVAL AS REPORTED. THE SAFETY RELEASE MECHANISM HAD BEEN ACTIVATED TO COLLAPSE THE LOCATOR WINGS TO FACILITATE DEVICE REMOVAL. DURING TESTING, THE RETURNED DEVICE WAS CLEANED, ASSEMBLED, AND DEPLOYED SUCCESSFULLY. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE PUSHER-TO-GARAGE BLOCK DISPLACEMENT AND SUBSEQUENT FAILURE TO DEPLOY THE CLIP AND COLLAPSE THE WINGS 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. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED DIFFICULT DEVICE REMOVAL AFTER CLIP DEPLOYMENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY RELEVANT MANUFACTURING RELATED NON-CONFORMING 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION. ESTIMATED AGE (REPORTED AS IN (B)(6)). ESTIMATED DATE (REPORTED AS OCCURRED WEEK OF (B)(6) 2011).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH ADDITIONAL INFORMATION RECEIVED THAT DURING DEVICE REMOVAL, THE STARCLOSE SE ACCESS PORTS WERE NOT USED (THIS IS NOT IN ACCORDANCE WITH IFU) PRIOR TO COUNTER-TRACTION AND ASSERTIVE PULL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE STARCLOSE SE DEVICE WAS DIFFICULT TO REMOVE FROM THE ANATOMY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE COUNTER-TRACTION AND ASSERTIVE PULL WAS USED TO REMOVED THE STARCLOSE SE DEVICE. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. 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 030206H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention