BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2042528 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02413
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT 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. THE PUSHER BLOCK DID NOT CONNECT WITH A COMPONENT AT 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 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS WITH REPORTED PREMATURELY DEPLOYED CLIP. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO SIMILAR INCIDENTS THAT EXHIBITED THE PUSHER-TO-GARAGE BLOCK DISPLACEMENT THAT SUBSEQUENTLY RESULTED IN A FAILURE TO FIRE THE CLIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP PREMATURELY DEPLOYED IN THE TISSUE TRACK. THE CLIP WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 010126H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention