BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM INTERFACE CABLE

    MDR report key: 2505715 · Received March 27, 2012

    Report

    Report Number
    2029046-2012-00035
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS MOMENT IT IS UNCLEAR THE REPROCESSING OF DEVICE. THE CONCOMITANT PRODUCTS: CARTO 3, MODEL # M-4800-01, SERIAL # (B)(4); SMART TOUCH BIDIRECTIONAL, MODEL # D-1327-04-S, LOT # 15486798M (NOT MARKETED IN US). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A-FLUTTER LEFT SIDE PROCEDURE, WHEN THE CATHETER WAS CONNECTED TO ITS CABLE CONNECTION, WHICH ALREADY HAD BEEN CONNECTED TO THE PIU, THE PATIENT RECEIVED A HEAVY SHOCK, WHICH COMPLETELY ERASED THE TRACES ON THE POLYGRAPH (TYPE SHOCK OF DEFIBRILLATION). THE DOCTOR FELT A STRONG HEATING OF THE HAND PIECE AND THE CARTO RETURNED AN ERROR - "ALERT 106 AN ERROR RELATED TO THE SMARTTOUCH CATHETER OCCURRED". THEN THEY REPLACED THE CABLE AND USED A NEW SMARTTOUCH CATHETER AND THE PROBLEM NO LONGER PRESENTED. THE CASE WAS COMPLETED WITHOUT ANY PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1