BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2101299 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03675
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CLIP WAS FULLY DEPLOYED. THE EXTERNAL AND INTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITIONS AND UNDAMAGED. THE DISTAL END OF THE CARRIER TUBE WAS ALSO EXAMINED AND CLIP TINE WITNESS MARKS WERE PRESENT EVIDENCING THE CLIP HAD BEEN DEPLOYED. THE LOCATOR WINGS WERE EXAMINED AND FOUND TO BE NORMAL FOR A DEPLOYED DEVICE AND NOT A CONTRIBUTING FACTOR IN THE EVENT. THERE WERE NO OBSERVATIONS FOUND WITH THE DEVICE THAT WOULD HAVE CONTRIBUTED TO THE REPORT RECEIVED OF THE CLIP BEING IMPLANTED, REMOVED AND THEN COMING APART. DURING TESTING THE DEVICE WAS CLEANED, RESET AND RE-DEPLOYED AND FUNCTIONED NORMALLY. THEREFORE, THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED BASED ON THE INVESTIGATION FINDINGS. THE REPORT OF THE CLIP BEING IMPLANTED AND CAME APART MOST LIKELY INDICATES THE CLIP DID NOT CLOSE THE ACCESS SITE AT DEPLOYMENT. THE DEVICE MISFIRING OR FAILING TO DELIVER THE CLIP AT THE INTENDED SITE CAN BE INFLUENCED BY MANY FACTORS THAT INCLUDE, BUT ARE NOT LIMITED TO: RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT WHICH CAN RESULT IN INCOMPLETE TISSUE CAPTURED AND CLIP DEPLOYMENT ABOVE THE ARTERY; FAILING TO RAISE THE DEVICE FROM 45 DEGREES TO 60 TO 75 DEGREES PRIOR TO CLIP DEPLOYMENT MAY ALSO RESULT IN INCOMPLETE TISSUE CAPTURED. BASED ON THE INVESTIGATION THE FAILURE TO CLOSE THE ACCESS SITE EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY ISSUE. TO HELP ENSURE 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 HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER PREVIOUS INCIDENTS REPORTED FOR DEVICE OPERATES DIFFERENTLY THAN EXPECTED FOR THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT 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 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 A RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE INFORMATION RECEIVED WITH THE DEVICE INDICATED THE CLIP WAS IMPLANTED, REMOVED, THEN CAME APART. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE MANUFACTURER REPRESENTATIVE RECEIVED THE DEVICE IN ONE PIECE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 950396H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention