BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEELEX ELEC 0 (3.5) 60CM HR26/GS65V

    MDR report key: 6048473 · Received October 21, 2016

    Report

    Report Number
    2916714-2016-00891
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 10, 2016
    Report Date
    February 13, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    LDF
    PMA / PMN Number
    K030556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. IT IS REPORTED THAT AFTER A PROCEDURE REPLACEMENT OF MITRAL VALVE WITH LAYING OF TWO VENTRICULAR ELECTRODES AND A PACEMAKER EXTERN, THE INNER PART OF THE ELECTRODES BROKE DURING DRESSING.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET, THERE ARE NO UNITS IN STOCK. REVIEWED THE BATCH MANUFACTURING RECORD THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED THE OEM REQUIREMENTS. THE STEELEX ELECTRODE SET IS A SPECIAL SURGICAL SET FOR TEMPORARY ELECTRO STIMULATION AFTER OPEN-HEART SURGERY, CLASSIFIED AS CF DEFIBRILLATION PROOF TYPE APPLIED PART ACCORDING TO IEC 60601-1. THE STEELEX ELECTRODE SET COMPRISES OF A STAINLESS STEEL TWISTED WIRE (AISI 316L), WITH A PLASTIC ISOLATING COVER (POLYETHYLENE). ONE END OF THE WIRE IS ARMED WITH A 1/2 CIRCLE OR 3/8 CIRCLE ROUND-BODIED NEEDLE AND THE OTHER END IS ARMED WITH A STRAIGHT NEEDLE (BREAK-OFF). THE STRAIGHT BREAK-OFF NEEDLE ALSO SERVES AS THE CONNECTION TO THE ADAPTER CABLE (NO. E4231, PACE MEDICAL INC.). AFTER A VISIT WITH THE CUSTOMER IT WAS UNDERSTOOD THAT THE STEELEX ELECTRODE SET HAD NOT BEEN USED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ELECTRODES ARE NOT SECURED IN THE EPICARDIUM WITH A SUTURE STITCH. IN THE WARNING NOTE PARAGRAPH OF THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS INFORMED THAT: ONLY SPECIALLY TRAINED PERSONNEL SHALL APPLY TEMPORARY PACING ELECTRODES AND THE ADAPTER CABLES. INSTRUCTIONS FOR USE FOR CONNECTING STEELEX ELECTRODE SET TO THE ADAPTER CONNECTOR SHALL BE FOLLOWED PRECISELY. DO NOT CONNECT THE STEELEX ELECTRODE SET DIRECTLY TO THE PACEMAKER. THE STEELEX ELECTRODE SET HAS TO BE FIRST CONNECTED TO AN ADAPTER CABLE (USE EXCLUSIVELY PACE LINE EXTENSION CABLE E4231) AND THEN THE ADAPTER CABLE TO THE PACEMAKER, AVOIDING ANY ACCIDENTAL CONTACT WITH OPERATOR OR OTHER APPARATUSES. THE WHITE LEAD HAS TO BE CONNECTED TO THE VENTRICULAR CHANNEL, MEANWHILE THE BLUE LEAD HAS TO BE CONNECTED TO ATRIAL CHANNEL. NEVER INSERT THE ELECTRODES OF THE ADAPTER CABLES INTO MAIN SOCKETS OR ELECTRIC ACCUMULATORS. ME EQUIPMENT/ACCESSORIES CONNECTED TO STEELEX ELECTRODE SET SHALL COMPLY WITH IEC 60601-1, TYPE CF APPLIED PART. COMPATIBILITY WITH OTHER ME EQUIPMENT/ACCESSORIES MUST BE CHECKED BEFORE USE. FINAL CONCLUSION: WITHOUT ANY CLOSED SAMPLES A STUDY CAN NOT BE PERFORMED TO SEE IF THE AFFECTED PRODUCT DOES NOT FULFILL THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENT AND IF ANY SAMPLES ARE RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND ANALYZED. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT WAS NOT BEING USED ACCORDING TO THE INSTRUCTIONS FOR USE. IT IS ASSUMED AN INCORRECT HANDLING/USAGE OF THE PRODUCT AS THE ROOT CAUSE OF THE INCIDENT, AS THE DEVICE WAS DIRECTLY CONNECTED TO THE PACEMAKER WHEN IT SHOULD BE FIRST CONNECTED TO AN ADAPTER CABLE. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698533 STEELEX ELEC 0 (3.5) 60CM HR26/GS65V CARDIAC SUTURE LDF B.BRAUN SURGICAL SA C0992100 116271V017

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other