BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM INTERFACE CABLE

    MDR report key: 4233109 · Received November 6, 2014

    Report

    Report Number
    9673241-2014-00465
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A C3 INTERFACE CABLE ¿ THERAPEUTIC, AND A BAD NO ECG ALL CHANNELS ¿ BS AND IC ISSUE OCCURRED. IT WAS REPORTED THAT THE STOCKERT 70 SYSTEM WAS CLICKING AND THE TEMPERATURE WAS GOING UP AND DOWN. ALL ECG¿S WERE NOISY. THE NOISE STARTED WHEN THE REDEL CABLE WAS PLUGGED INTO THE PATIENT INTERFACE UNIT (PIU). THE REDEL CABLE AND THE ABLATION ADAPTER WERE REPLACED WITHOUT RESOLUTION. THERE WAS NO CATHETER PLUGGED INTO THE ABLATION CABLE THAT IS PLUGGED INTO THE PIU. WHEN THE C3 INTERFACE CABLE-THERAPEUTIC WAS REMOVED, THE NOISE WENT AWAY AND THERE WAS NO LONGER ANY TEMPERATURE ON THE STOCKERT, AS IT SHOULD BE. THE C3 INTERFACE CABLE-THERAPEUTIC WAS REPROCESSED MANY TIMES. A NEW CABLE WAS PLUGGED IN AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED WITHOUT PATIENT CONSEQUENCE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE NOISE WAS OBSERVED ON ALL THE BODY SURFACE (BS) AND INTRACARDIAC (IC) CHANNELS ON BOTH THE CARTO SYSTEM AND THE PRUKA RECORDING SYSTEM AND THERE WAS NO SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE ISSUE WAS A BENT PIN IN THE ABLATION SOCKET. IT WAS IN CONTACT WITH THE PIN NEXT TO IT. ONCE IT WAS REPLACED, THE ISSUE WAS RESOLVED. THE TEMPERATURE ISSUE WAS FOUND BEFORE USE. NO ENERGY COULD BE DELIVERED SINCE THERE WAS NO ABLATION CATHETER CONNECTED TO THE STOCKERT GENERATOR. VALUES WERE NOT CHECKED AT THE TIME OF THE ISSUE AS THERE WAS NO ABLATION CATHETER. THE STOCKERT GENERATOR WAS PROGRAMMED WITH THE DEFAULT VALUES FOR THE 8MM CATHETER. SINCE THE NOISE AFFECTED ALL IC AND BS SIGNALS ON BOTH THE CARTO SYSTEM AND THE PRUKA RECORDING SYSTEM AND THERE WAS NO SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM, THIS EVENT IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714984 CARTO® 3 SYSTEM INTERFACE CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, INC. (JUAREZ) D-1286-03-S UNKNOWN_D-1286-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1