BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2133944 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04347
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE EXCHANGE SHEATH WAS NOT COMPLETELY SLIT AND THE VESSEL LOCATOR WINGS WERE STILL IN DEPLOYED POSITION. THE THUMB ADVANCER WAS APPROXIMATELY 3/4 INCHES FROM COMPLETION. BASED ON THE CONDITION OF THE DEVICE THE REPORTED EXPERIENCE IS CONFIRMED. THE DEVICE WAS DISASSEMBLED AND THE CATCH WAS STILL LOADED. THE DEVICE WAS CLEANED, REASSEMBLED AND RESET FOR TESTING. THE CLIP WAS REMOVED FOR SAFETY. THE THUMB ADVANCER WAS ABLE TO ADVANCE TO THE FINISH POSITION AND THE SHEATH WAS SLIT COMPLETELY. THE RETURNED DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS AND THERE WAS NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A POSSIBLE CAUSE FOR THE DEVICE TO PULL OUT OF THE ARTERY IS IF EXCESSIVE TENSION HAD BEEN APPLIED WHEN PLACING THE LOCATOR WINGS AGAINST THE ANTERIOR WALL OF THE ARTERY. BASED ON THE EVALUATION AND THE REPORTED EXPERIENCE THE PROBABLE CAUSE FOR THE EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER CASES OF LOSS OF ARTERIAL ACCESS EVENTS WITH THE SAME LOT NUMBER. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE SE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, PULSATILE BLOOD WAS NOTED AROUND THE SHEATH AT THE ARTERIAL WALL AND WITH THE VESSEL LOCATOR WINGS IN THE OPEN POSITION, AS THE DEVICE WAS BEING POSITIONED, IT CAME OUT OF THE ARTERY. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 040086H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention HEPARIN, INTEGRILIN