BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1936187 · Received December 22, 2010

    Report

    Report Number
    2953144-2010-03344
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FULLY CLIP DEPLOYED. THE THUMB ADVANCER WAS LOCKED INTO POSITION. THE PROXIMAL ENDS OF TWO VESSEL LOCATOR RIBBONS WERE DETACHED FROM THE PUSHER BODY AND PROTRUDING OUT OF THE DISTAL END OF THE TUBESET. THE TRIGGER BUTTON HAD RELEASED THE CATCH AND PUSHER BLOCK DEPLOYING THE CLIP. AT CLIP DEPLOYMENT, THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH CLIP DELIVERY; HOWEVER, TWO OF THE LOCATOR WINGS OF THIS DEVICE, DID NOT COLLAPSE INTO THE TUBESET, BUT WERE DETACHED AND PROTRUDING OUT OF THE TUBESET. A CONTRIBUTING FACTOR FOR THE DISPLACED VESSEL LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES RESULTING IN BENDING OR BREAKAGE OF THE LOCATOR WINGS. THE RELEASE BUTTON/ROD HAD BEEN PUSHED INWARD OUT OF ITS RETAINING TAB, WHICH INDICATES THAT AN ATTEMPT WAS MADE TO USE THE SAFETY RELEASE TO REMOVE THE DEVICE PRIOR TO USING THE ACCESS PORTS TO RETRACT THE THUMB ADVANCER. THERE WAS NO INDICATION THAT THE ACCESS PORT RELEASE FUNCTION HAD BEEN USED AS INSTRUCTED IN THE INSTRUCTIONS FOR USE. FAILURE TO COMPLETE THIS PROCESS INCREASES THE FORCES APPLIED TO THE VESSEL LOCATOR WINGS DURING REMOVAL. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE DAMAGED DETECTED IS RELATED TO INCORRECT TECHNIQUE AND OPERATIONAL CONTEXT. THE DETACHMENT OF THE VESSEL LOCATOR RIBBONS IS POTENTIONALLY MANUFACTURING RELATED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING USED A STARCLOSE SE DEVICE TO ATTEMPT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER ALL THE STEPS WERE FOLLOWED AND THE CLIP WAS FIRED, IT WAS FOUND THAT THE CLIP DID NOT RELEASE FROM THE DEVICE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 920266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention