BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO¿ 3 SYSTEM

    MDR report key: 2190433 · Received August 4, 2011

    Report

    Report Number
    9681484-2011-00014
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER INITIALIZING THE CATHETERS ON THIS SYSTEM, ALL BODY SURFACE AND INTRACARDIAC ECG SIGNALS BECAME EXTREMELY NOISY AND ALL SIGNALS WERE LOST ON BOTH THE BARD AND CARTO 3 SYSTEMS. THIS HAPPENED RIGHT AFTER COMPLETING THE CONTOURS FOR THE SOUND PORTION AND WHILE THE PHYSICIAN WAS GOING TRANSSEPTAL. NO ABLATION HAD BEEN STARTED AND NO CARDIOVERSION WAS BEING PERFORMED. THE CASE WAS SWITCHED TO ESI AFTER 2.5 HOURS OF TROUBLE SHOOTING OF THE TWO SYSTEMS. THE TWO CARTO 3 SYSTEMS LOCATED AT THE HOSPITAL WERE USED TO TROUBLESHOOT THE ISSUE. IT WAS FOUND THAT DEFECTIVE CATHETER EXTENSION CABLES CAUSED THE ISSUE. THE DEFECTIVE CABLES WERE TESTED WITH BOTH SYSTEMS AND CAUSED THE SAME REPORTED PROBLEM. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. COMPLAINT CONDITION WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER INITIALIZING THE CATHETERS ON THIS SYSTEM, ALL BODY SURFACE AND INTRACARDIAC ECG SIGNALS BECAME EXTREMELY NOISY AND ALL SIGNALS WERE LOST ON BOTH THE BARD AND CARTO 3 SYSTEMS. THIS HAPPENED RIGHT AFTER COMPLETING THE CONTOURS FOR THE SOUND PORTION AND WHILE THE PHYSICIAN WAS GOING TRANSSEPTAL. NO ABLATION HAD BEEN STARTED AND NO CARDIOVERSION WAS BEING PERFORMED. THE CASE WAS SWITCHED TO ESI AFTER 2.5 HOURS OF TROUBLE SHOOTING OF THE TWO SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO¿ 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1