BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, ELECTRODE RECORDING

    MDR report key: 3934821 · Received July 15, 2014

    Report

    Report Number
    2029046-2014-00196
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P010068/S2
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE DEVICE WAS DISPOSED OF AND NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: 1. LASSO 2515 NAV VARI, MODEL# D-1290-01-S, LOT# UNK; 2. EZ STEER THERMOCOOL NAVIGATION, MODEL# D-1292-01-S, LOT# UNK. 3. CARTO 3, MODEL# AND LOT# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE INVOLVING BIOSENSE WEBSTER NAVIGATIONAL CABLES (MODEL NUMBER AND LOT NUMBER UNKNOWN), AND A NOISE DEVICE MALFUNCTION OCCURRED. DURING THE CASE, THE PHYSICIAN DISCOVERED THAT THERE WAS SIGNAL NOISE ON ALL AVAILABLE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE (BS) AND ALL INTRACARDIAC (IC) SIGNALS. NOISE WAS VISUALIZED ON BOTH THE CARTO MAPPING SYSTEM AND THE EP RECORDING SYSTEM AT THE SAME TIME, WHICH MADE IT VERY HARD TO PROCEED WITH THE CASE, ACCORDING TO THE PHYSICIAN. THE PHYSICIAN HAD NO AVAILABLE EKG OR INTRACARDIAC SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. WHILE TROUBLE-SHOOTING THE ISSUE, THE CATHETERS WERE REPLACED, BUT IT WAS DETERMINED BY THE PHYSICIAN THAT THE CABLES WERE THE CAUSATIVE DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414118 CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) NAVIGATIONAL CABLES UNKNOWN_NAVIGATIONAL CABLES

    Patients

    Seq Age Sex Outcome Treatment
    1