BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1923942 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03220
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    June 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED. THE THUMB ADVANCER DEPLOYMENT REMAINED IN THE COMPLETION WINDOW AND THE LOCATOR WINGS REMAINED DEPLOYED. THESE FINDINGS INDICATE THE ACCESS PORT RELEASE FUNCTION WAS NOT ACTIVATED WHICH IS INCONSISTENT WITH THE REPORTED EVENT. 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 WOULD RESULT IN DIFFICULTY WITH DEPLOYMENT OF THE THUMB ADVANCER AND PREVENTED SUCCESSFUL 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. 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.

    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 THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER FULLY COMPLETING THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING, THE CLIP DID NOT DEPLOY AFTER DEPRESSING THE DEPLOYMENT BUTTON. THE SAFETY RELEASE WAS ACTIVATED, RETRACTING THE LOCATOR WINGS, WHICH RELEASED THE DEVICE FROM THE PATIENT ANATOMY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-REDWOOD CITY 890096H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention