BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 3839468 · Received May 29, 2014

    Report

    Report Number
    2015691-2014-01253
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    GDZ
    PMA / PMN Number
    K923367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: A MODEL 1150 HANDLE AND ANNULOPLASTY RING HOLDER WERE RETURNED AND EVALUATED BY ENGINEERING. AS REPORTED, THE CUSTOMER CONNECTED THE RING HOLDER TO ITS HANDLE IN ORDER TO START PASSING THE SUTURES THROUGH THE RING AS PER PROCEDURE. WHEN PASSING THE FIRST SUTURE, THE CONNECTION BETWEEN THE HANDLE AND THE RING HOLDER BROKE AND THE SUTURING AND PARACHUTING COULD NOT BE COMPLETED. AS RECEIVED, THE SNAP ASSEMBLY OF THE MODEL 1150 HANDLE WAS BROKEN OFF. THE BROKEN PIECE WAS APPROXIMATELY 7MM IN LENGTH AND APPEARED TO MATCH UP TO THE HANDLE END. THE MALLEABLE PART OF THE HANDLE WAS BENT SLIGHTLY. ROOT CAUSE ANALYSIS: BASED ON THE EVALUATION DONE BY ENGINEERING, THE ROOT CAUSE OF THE SNAP ASSEMBLY BREAKING COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS LIKELY DUE TO THE HANDLING OF THE DEVICE. THE RETAINING SUTURES CONNECTING THE TEMPLATE AND LANYARD ASSEMBLY APPEARED TO BE LOOSE. THE LOOSE CONNECTION SUGGESTS A LARGE AMOUNT OF FORCE WAS USED WHEN IMPLANTING THE DEVICE. IT IS UNLIKELY THE SUTURES WERE LOOSE PRIOR TO IMPLANTING THE DEVICE BECAUSE THERE IS A 100 PERCENT VISUAL INSPECTION TO VERIFY THE CORRECT CARTRIDGE ATTACHMENT IS SEATED AGAINST THE TEMPLATE PER PROCEDURE. IT IS POSSIBLE THIS LARGE FORCE CAUSED THE SNAP ASSEMBLY TO BREAK. THE MODEL 1150 HANDLE IS DESIGNED TO BE REUSABLE AND THE SNAP-FIT INSERTION AND REMOVAL FORCE BE BETWEEN 600 GRAMS AND 3500 GRAMS AFTER 30 STERILIZATION CYCLES. CORRECTIVE ACTION: BASED ON THE AVAILABLE INFORMATION, NO CORRECTIVE ACTION WILL BE TAKEN AS THIS EVENT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THERE WERE NO REPORT OF PARTICLES COMING INTO CONTACT WITH THE PATIENT AND THE BROKEN PIECE APPEARED TO MATCH WITH THE HANDLE. A REVIEW OF COMPLAINTS FOR THE MODEL 1150 HANDLE FOR THE PAST 2 YEARS WAS CONDUCTED, AND THERE APPEARS TO BE ONE SIMILAR EVENT IN WHICH THE SNAP ASSEMBLY OF AN 1150 HANDLE BROKE. HOWEVER, IT OCCURRED PRIOR TO USE BEING INTRODUCED TO THE PATIENT. THE INSTRUCTIONS FOR USE (IFU) STATE THE MODEL 1150 HANDLE MAY BE UTILIZED IN CONJUNCTION WITH THE HOLDER TO FACILITATE EASE OF SUTURE PLACEMENT AND IMPLANTATION. INSERTION OF THE MITRAL PROSTHESIS MAY BE ACCOMPLISHED WITH THE HANDLE AND HOLDER, WITH THE HOLDER ALONE, OR WITHOUT EITHER HOLDER OR HANDLE.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT OF BROKEN HANDLE WAS CONFIRMED. AS RECEIVED, CONNECTION POINT OF HANDLE WAS BROKEN OFF, BROKEN PIECE WAS APPROX 7MM IN LENGTH. BROKEN PIECE APPEARED TO MATCH UP WITH HANDLE END. AS RECEIVED, MALLEABLE PART OF HANDLE WAS BENT SLIGHTLY. ADDITIONAL FOLLOW UP WAS REQUESTED FOR ADDITIONAL INFORMATION REGARDING THE LENGTH OF TIME THIS DEVICE HAS BEEN IN SERVICE, MAINTENANCE INFORMATION, AND NUMBER OF TIMES STERILIZED. BECAUSE THIS IS NOT A SERIALIZED DEVICE, WE ARE UNABLE TO PERFORM A DEVICE HISTORY RECORD (DHR) REVIEW. HOWEVER, THE DEVICE IS CURRENTLY UNDER REVIEW WITH RESEARCH AND DEVELOPMENT. OUR FINDINGS WILL BE REPORTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTEDLY, THE RE-USABLE HANDLE TO AN ANNULOPLASTY RING BROKE AFTER IT HAD BEEN ATTACHED TO THE RING TEMPLATE. NO PIECES FELL INTO THE PATIENT AND ANOTHER RING WAS CHOSEN AND IMPLANTED WITHOUT ISSUE. AS REPORTED, THE DEVICE WAS CHOSEN AFTER SIZING AND SELECTION OF APPROPRIATE RING TO IMPLANT. THEY OPENED THE BOX, THEY OPENED THE INTERNAL BLISTER AND THEY CONNECTED THE RING HOLDER TO ITS HANDLE IN ORDER TO START PASSING THE SUTURES THROUGH THE RING, AS PER PROCEDURE. WHEN PASSING THE FIRST SUTURE, THE CONNECTION BETWEEN THE HANDLE AND THE RING HOLDER BROKE NOT ALLOWING ANYMORE TO COMPLETE RING SUTURING AND PARACHUTING. ANOTHER RING SAME MODEL AND SIZE WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316668 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM HANDLE, SCALPEL GDZ EDWARDS LIFESCIENCES 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR