BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3253217 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04746
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEPLOYMENT BUTTON WAS DEPRESSED TO FIRE THE CLIP, THE CLIP TINES PUNCTURED INTO THE SHEATH AT THE DISTAL END, RESULTING IN THE CLIP BEING CAPTURED AT THE DISTAL END OF THE SHEATH INSTEAD OF BEING FULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE ACCESS SITE AS INTENDED. THE REPORTED UNSATISFACTORY CLOSE WITH THE STARCLOSE SE DEVICE IS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE IS RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE, WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AN "UNSATISFACTORY CLOSE" WITH THE STARCLOSE SE DEVICE OCCURRED. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE MECHANISM ACCESS PORTS WERE USED TO SUCCESSFULLY FACILITATE DEVICE REMOVAL. A NON-ABBOTT DEVICE AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352796 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30419K1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 6F