BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2912290 · Received January 11, 2013

    Report

    Report Number
    3008203003-2013-00009
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2012
    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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE ANALYSIS REPAIR INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CUSTOMER WAS NOT ABLE TO PACE FROM THE ABLATION CATHETER. A NEW SYSTEM WAS INSTALLED IN THE ACCOUNT AND THE ECG CARDS WERE NOT TRANSFERRED TO THE NEW SYSTEM. THE OLD CABLE SETUP WAS INSTALLED AND IT FAILED TO BYPASS THE CARTO 3 SYSTEM. ULTIMATELY THE PHYSICIAN COULD NOT PERFORM PACING. A TECHNICAL SERVICE REPRESENTATIVE ARRIVED AT THE HOSPITAL AND IT WAS FOUND THAT THE SYSTEM HAD THE OLD REVISION OF ECG CARDS; THEREFORE IT DID NOT SUPPORT THE PASS THROUGH PACING. NEW REVISION OF ECG CARDS WAS INSTALLED INTO THE SYSTEM AND THE PROBLEM WAS SOLVED. THE DHR ASSOCIATED WITH CARTO 3 (B)(4) WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CUSTOMER WAS NOT ABLE TO PACE FROM THE ABLATION CATHETER. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION OF THE EVENT ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THIS WAS A HW PACING ISSUE. A NEW SYSTEM WAS INSTALLED IN THE ACCOUNT AND THE ECG CARDS WERE NOT TRANSFERRED TO THE NEW SYSTEM. THE OLD CABLE SETUP WAS INSTALLED AND IT FAILED TO BYPASS THE CARTO 3 SYSTEM. ULTIMATELY THE PHYSICIAN COULD NOT PERFORM PACING. ALTHOUGH THE PHYSICIAN DID NOT CONSIDER THAT THERE WAS ANY POTENTIAL RISK TO THE PATIENT BECAUSE HE HAD A RV CATHETER CONNECTED TO THE GE RECORDING SYSTEM FOR EMERGENCY PACING; HOWEVER, IT WAS CONFIRMED BY THE CUSTOMER THAT THE PHYSICIAN WAS NOT ABLE TO USE THE DIRECT PACING PORT IN THE PIU. BASED ON ADDITIONAL INFORMATION RECEIVED, THE EVENT WAS CONSIDERED REPORTABLE DATING ALERT DATE AS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17051 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1