BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER OPTIC CABLE - DUPLEX LC/LC 30M

    MDR report key: 21790861 · Received April 7, 2025

    Report

    Report Number
    2184149-2025-00071
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL H700180) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6 ONE FIBER OPTIC CABLE - DUPLEX LC/LC 30M WAS RECEIVED FOR EVALUATION. THE CABLE WAS CONNECTED TO A KNOWN-GOOD AMPLIFIER AND A COMPUTER WITHIN A TEST STATION. THE CABLE WAS CONNECTED, AND COMMUNICATION WAS NOT ESTABLISHED WITH DUPLICATED THE REPORTED SYMPTOM. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION AND INVESTIGATION PROVIDED TO ABBOTT, THE ROOT CAUSE OF THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT DELAY WAS DUE TO A SIGNAL LOSS WITHIN THE CABLE.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 2184149-2025-00060, 2184149-2025-00070. DURING AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUED OCCURRED CAUSING A DELAY. THE ENSITE X WAS USED WITH FARAWAVE NAVX MODE, AND COMMUNICATION BETWEEN THE AMPLIFIER AND DWS WAS INTERRUPTED TOWARD THE END OF POST MAPPING AFTER PULSE FIELD ABLATION. A "COMMUNICATION FAILURE" ALERT POP-UP WAS DISPLAYED, AND THE ELECTRIC POTENTIAL WAVEFORM BECAME PURPLE FLAT. AMPLIFIER RECONNECT AND RESET AMPLIFIER WERE PERFORMED FROM THE DWS SIDE, BUT THE ALERT PERSISTED. DURING THAT TIME, THE LAMP NEXT TO THE AMPLIFIER POWER BUTTON WAS FLASHING GREEN, AND THE LAMP AT THE OPTICAL CABLE PORT ON THE DWS WAS NOT LIT. THE LAMP ON THE AMPLIFIER SIDE WAS LIT ORANGE. THE OPTICAL CABLE WAS EXCHANGED, THE CABLES ON THE PANELS OF THE AMPLIFIER WERE REMOVED AND THE POWER OF DWS AND AMPLIFIER WERE TURNED OFF. THE DWS WAS THEN STARTED UP, AND THE AMPLIFIER WAS STARTED UP AS PER PROPER INSTRUCTIONS, BUT COMMUNICATION WAS NOT RESTORED. THE AMPLIFIER POWER LAMP WAS FLASHING GREEN AND THE DWS OPTICAL CABLE LAMP REMAINED OFF. DWS RESTART WAS PERFORMED 4 TIMES, BUT COMMUNICATION WAS NOT RESTORED. THEREFORE, IT WAS NOT POSSIBLE TO CONTINUE NAVIGATION USING ENSITE, AND IT WAS SWITCHED TO ABLATION UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE X DWS WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INSPECTION AT THE DISTRIBUTOR DETERMINED THAT THE CAUSE OF THE COMMUNICATION ISSUE WAS DUE TO THE FIBER OPTICAL CABLES HAVING DETERIORATED OVER TIME AND COMMUNICATION WAS NO LONGER POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646584 FIBER OPTIC CABLE - DUPLEX LC/LC 30M COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENSITE VELOCITY¿ FIBER OPTIC CABLE DUPLEX.| ENSITE¿ X DISPLAY WORKSTATIO.