BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2082260 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03297
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE THUMB ADVANCER HAD BEEN RETRACTED APPROXIMATELY 2 MM PROXIMAL OF ITS COMPLETION (STEP #3). THE RETRACTION OF THE THUMB ADVANCER IS CONSISTENT WITH THE REMOVAL OF THE DEVICE WHEN RESISTANCE IN ENCOUNTERED DURING DEPLOYMENT EITHER DURING THUMB ADVANCEMENT AND/OR REMOVAL. DURING INTERNAL EXAMINATION THE VESSEL LOCATOR WINGS WERE FOUND TO BE BENT. DURING CLIP DEPLOYMENT THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT. THE PROBABLE CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE TUBES AND OPEN LOCATORS. THIS CREATED A DISTAL FORCE DURING THUMB ADVANCEMENT, BENDING THE LOCATOR WINGS RESULTING IN A STUCK DEVICE. THE RELEASE ROD WAS ALSO FOUND TO HAVE BEEN PUSHED OUT OF ITS RETAINING TABS. THE DAMAGE DETECTED WITH THE SAFETY RELEASE ROD INDICATES AN ATTEMPT WAS MADE TO COLLAPSE THE VESSEL LOCATOR WINGS USING THE SAFETY RELEASE BUTTON, AFTER THE CLIP WAS DEPLOYED BUT BEFORE THE THUMB ADVANCER WAS RETRACTED. THE SAFETY RELEASE IS NO LONGER FUNCTIONAL AFTER THE CLIP HAS BEEN DEPLOYED. BASED ON THESE FINDINGS THE REPORTED DIFFICULT REMOVAL IS CONFIRMED AND CLIP DEPLOYMENT IN THE DISTAL END OF THE DEVICE IS CONFIRMED. PER THE INSTRUCTIONS FOR USE, IT STATES THAT THE RELEASE ROD SHOULD BE SLID IN ORDER TO COLLAPSE THE VESSEL LOCATOR WINGS. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED DIFFICULT REMOVAL EXPERIENCED, APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL 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 COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYMENT, THE DEVICE WAS STUCK AND DIFFICULTY WAS ENCOUNTERED WHILE REMOVING THE IT. PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED, BUT IT WAS REPORTED TO BE 'HARD'. 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 940026H

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention