BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 4093612 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05955
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPROPER OR INCORRECT PROCEDURE OR METHOD - FAILURE TO FOLLOW STEPS/INSTRUCTIONS FOR PROSTAR XL. TECHNIQUE FOR NEEDLE BACK-DOWN. PERFORM THE SAME NEEDLE BACK-DOWN PROCEDURE IN THE EVENT THAT ALL NEEDLES ARE NOT DEPLOYED. DO NOT REMOVE ANY DEPLOYED NEEDLES. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE PROSTAR INSTRUCTIONS FOR USE STATES, PERFORM THE SAME NEEDLE BACK-DOWN PROCEDURE IN THE EVENT THAT ALL NEEDLES ARE NOT DEPLOYED. DO NOT REMOVE ANY DEPLOYED NEEDLES. TWO UNUSED STERILE PROGLIDE DEVICES WITH THE SAME LOT NUMBER, 31126K1, AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE UNUSED, STERILE DEVICES. ALL FOUR NEEDLES EMERGED AT THE TOPE OF THE BARREL SUCCESSFULLY. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT OF A PROSTAR XL DEVICE WAS ACHIEVED IN THE LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. REPORTEDLY, THREE NEEDLES WERE DEPLOYED; HOWEVER, THE FOURTH NEEDLE FAILED TO APPEAR. IT WAS FOUND THAT THE FOURTH NEEDLE CAME THROUGH THE SKIN OF THE PATIENT AND THE PHYSICIAN PULLED IT OUT OF THE SKIN. HEMOSTASIS WAS ACHIEVED WITH THE SUTURES FROM THE THREE NEEDLES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. 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
    572883 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31126K1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR