BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2011157 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01532
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP-DEPLOYED WITH ALL EXTERNAL AND INTERNAL COMPONENTS IN APPROPRIATE POST CLIP-DEPLOYMENT POSITION. CLIP TINES MARK WAS OBSERVED ON THE CARRIER TUBE, INDICATING THAT A CLIP WAS ORIGINALLY LOADED ON THE CARRIER TUBE AND FIRED DURING USE. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD INTERFERE WITH THE CLIP DEPLOYMENT AS THE SHEATH WAS FULLY SLIT AND THE VESSEL LOCATOR WINGS WERE FULLY COLLAPSED. THE CLIP LOADING IS 100% VERIFIED VIA THE VISIONING SYSTEM DURING MANUFACTURING; THEREFORE, THE PRESENCE OF A SECOND CLIP IN THE DEVICE IS NOT POSSIBLE. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND A ROOT CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. PATIENT BODILY MOVEMENT DURING THE PROCEDURE COULD RESULT IN THE CLIP BEING MISFIRED AS REPORTED. HOWEVER, BECAUSE THE CLIP WAS NOT RETURNED WITH THE DEVICE, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO INCIDENTS WITH SIMILAR REPORTED PRODUCT EXPERIENCE. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PATIENT WAS REPORTED TO BE OF (B)(6). 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 TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER SUCCESSFUL DEVICE DEPLOYMENT, IT WAS REMOVED FROM THE ANATOMY AND MANUAL PRESSURE WAS HELD FOR 3 MINUTES TO STOP THE OOZING. HOWEVER, AFTER DEVICE REMOVAL, THE CLIP OF THE DEVICE WAS OBSERVED TO BE PRESENT OUTSIDE THE ANATOMY, ON A TOWEL COVERING THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 950026H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention