BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2072165 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02980
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE STARCLOSE SE USED IN THE LEFT COMMON FEMORAL ARTERY, IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE EXTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITIONS AND UNDAMAGED. THE VESSEL 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 CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED BY THE ANALYSIS OF THE RETURNED DEVICE. SOME OF THE POSSIBLE CAUSES TO CONSIDER AS STATED IN THE INSTRUCTIONS FOR USE AND TRAINING GUIDE FOR A CLIP MISFIRE OR PARTIAL CLIP CAPTURE, MAY BE INFLUENCED BY BUT NOT LIMITED TO, MANUFACTURING, REFRACTION OF THE DEVICE DURING CLIP DEPLOYMENT CAN RESULT IN INCOMPLETE TISSUE CAPTURE AND CLIP DEPLOYMENT ABOVE THE ARTERY, DURING CLIP DEPLOYMENT STABILIZING THE BODY OF THE DEVICE WITH THE RIGHT HAND AND SUPPORTING THE CLIP DELIVERY TUBE WITH THE LEFT HAND, RAISE THE BODY OF THE DEVICE TO A 60 TO 75 DEGREE ANGLE DURING CLIP DEPLOYMENT. HOLDING THE DEVICE AT AN IMPROPER ANGLE DURING CLIP DEPLOYMENT CAN ALSO CAUSE INCOMPLETE TISSUE CAPTURE BY THE CLIP RESULTING IN ARTERIAL BLEEDING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INSPECTION CRITERIA AND THE ANALYSIS OF THE RETURNED DEVICE, THE REPORTED CLIP NOT TAKING AND NOT ACHIEVING HEMOSTASIS COULD NOT BE CONFIRMED AND NO CAUSE COULD BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED.

    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 RIGHT AND LEFT COMMON FEMORAL ARTERIES AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, "THE CLIP DID NOT TAKE" IN BOTH GROINS AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 950096H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention