BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2111938 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03849
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A FULLY ENGAGED PLUNGER WITH A FULLY DEPLOYED THUMB ADVANCER AND A COMPLETELY SPLIT SHEATH. THE TUBESET WAS OBSERVED TO BE MISALIGNED AND THE CLIP WAS FOUND TO BE CAUGHT IN THE DAMAGED LOCATOR WINGS. THREE OF THE VESSEL LOCATOR WINGS WERE OBSERVED TO BE BENT AND ONE WAS DETACHED FROM THE DISTAL RETAINING RING BUT REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. HOWEVER, THE CLIP WAS DRAGGED OFF THE CARRIER TUBE AND CAUGHT WITHIN THE LOCATOR DURING THE DEVICE REMOVAL AS OBSERVED. INTERNAL INSPECTION 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 OR 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 DISPLACED PUSHER-TO-GARAGE BLOCK DURING THE THUMB ADVANCER DEPLOYMENT CREATED RESISTANCE TO ADVANCING THE THUMB ADVANCER AND SPLITTING OF THE SHEATH. HOWEVER, THUMB ADVANCER DEPLOYMENT AND SHEATH SLIT WERE COMPLETE, INDICATING ADDITIONAL FORCE WAS APPLIED. THE FAILURE TO COLLAPSE THE WINGS WOULD RESULT IN DIFFICULTY REMOVING THE DEVICE; HOWEVER, THIS WAS NOT REPORTED. THE FULLY ENGAGED PLUNGER AND THUMB ADVANCER INDICATE THAT THE ACCESS PORTS WERE NOT USED TO FACILITATE DEVICE REMOVAL AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). THE DAMAGED LOCATOR WINGS ARE INDICATIVE OF THE DEVICE BEING PULLED OUT OF THAT PATIENT ANATOMY WHILE THEY WERE OPEN. THE INSTRUCTIONS FOR USE, STATES THAT IF RESISTANCE IS MET UPON REMOVAL OF THE DEVICE, USE THE ACCESS PORTS TO RELEASE THE LOCKING MECHANISM ON THE THUMB ADVANCER. AFTER RETRACTING THE THUMB ADVANCER AS FAR PROXIMAL AS POSSIBLE UNTIL RESISTANCE IS FELT, THE SAFETY RELEASE IS SLID TO COLLAPSE THE LOCATOR WINGS AND RESET THE PLUNGER. BASED ON THE INVESTIGATION DETAILS, 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 REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NO SEEM TO BE ANY INDICATION OF A LOT SPECIFIC QUALITY DEFICIENCY.

    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 WILL BE SUBMITTED WITH ALL 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 THE FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, WHEN THE DEVICE WAS REMOVED, THE CLIP WAS OBSERVED TO BE LOCATED ON THE DISTAL END OF THE DEVICE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 030296H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention