BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3160042 · Received June 10, 2013

    Report

    Report Number
    2024168-2013-03637
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED CONDITION COULD NOT CONFIRM THE REPORTED INCOMPLETE SHEATH SPLITTING AS THE SHEATH WAS FULLY SLIT. HOWEVER, THE REPORTED FAILURE TO FIRE THE CLIP IS CONFIRMED. INSPECTION OF THE RETURNED DEVICE INDICATED THAT A PUSHER-TO-GARAGE BLOCK DISPLACEMENT OCCURRED DURING THE THUMB ADVANCER DEPLOYMENT WHICH PROHIBITED THE PUSHER BLOCK FROM BEING ABLE TO PUSH THE CLIP OFF THE CARRIER TUBE WHEN THE TRIGGER/DEPLOYMENT BUTTON WAS DEPRESSED. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE 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.

    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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP WOULD NOT DELIVER AND REMAINED ON THE END OF THE DEVICE. THE SHEATH APPEARS NOT TO HAVE SPLIT COMPLETELY. 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
    259457 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30204K1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SHEATH: 6FR