BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5482091 · Received March 4, 2016

    Report

    Report Number
    3008203003-2016-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    December 31, 2015
    Report Date
    January 10, 2016
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO 3 SYSTEM. DURING THE PROCEDURE, ERROR 442 (ALERT 442 PATCH 3: MAGNETIC DISTORTION) KEPT APPEARING. THERE WAS MAGNETIC DISTORTION AND THEREFORE FAILED TO MAP. THE PROCEDURE WAS PROLONGED BY 120 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. INFORMATION FROM THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER REPORT WAS THAT IT WAS A PATCHES ERROR AND OUT OF SETUP ZONE. THERE WAS A PATIENT INTERFACE UNIT (PIU) ISSUE WITH LOC RX CARD. PERFORMED THE PIU LOCATION PAD (LP) KIT REPLACEMENT AND TESTED SUCCESSFULLY. THE SYSTEM WAS OPERATIONAL. REPLACED THE PIU AND THE LP KIT WAS SENT TO THE DEVICE MANUFACTURER FOR INVESTIGATION. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE LOC RX CARD IN THE PIU WAS FOUND FAULTY AND CAUSED THE ISSUE. THE FAULTY CARD WAS REPAIRED AND THE PIU RETURNED TO THE NORMAL FUNCTIONING. THE LP THAT ARRIVED AS A PART OF KIT WITH THE PIU WAS TESTED AND FOUND OPERATIONAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    BIOSENSE WEBSTER RECEIVED AN ERROR IN THE 3500A INITIAL ELECTRONIC SUBMISSION. THEREFORE, WE SENT THE REPORT MANUALLY ON (B)(6) 2016 VIA CERTIFIED/RETURN RECEIPT TO THE FDA. ON (B)(6) 2016 WE RECEIVED A LETTER FROM THE FDA STATING TO RESUBMIT THIS REPORT ELECTRONICALLY. THEREFORE, WE ARE RESUBMITTING THE INITIAL PER THE FDA'S REQUEST. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(6). MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO 3 SYSTEM. DURING THE PROCEDURE, ERROR 442 KEPT APPEARING. THERE WAS MAGNETIC DISTORTION AND THEREFORE FAILED TO MAP. THE PROCEDURE WAS PROLONGED BY 120 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE REPORTED ISSUES WERE ASSESSED AS REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON (B)(6) 2016. THEY CONTINUED THE PROCEDURE BY LIFTING THE PATIENT UP SO THAT THE MAPPING ZONE OF THE PATCH WAS WITHIN THE MAPPING ZONE. THEY ALSO ENSURED THAT ALL THE MAGNETIC METAL AROUND THE PATIENT WAS PUSHED AWAY. THEY WERE THEN ABLE TO MAP FOR A WHILE, BUT THEN INTERMITTENTLY FAILED TO MAP. THEY THEN COULD NO LONGER SEE THE PATCHES IN THE MAPPING ZONE. THEY DISCONTINUED RELYING ON THE CARTO 3 SYSTEM. THE PATIENT WAS WELL. HOWEVER, THE RESULTS WERE NOT SATISFACTORY. THE PATIENT MIGHT NEED TO COME IN AGAIN IF REQUIRED. THE PHYSICIAN CONSIDERED THAT THE DELAY CAUSED A POTENTIAL RISK TO THE PATIENT AS THE PATIENT WAS UNDER GENERAL ANESTHESIA AND NEEDED PROLONGED MEDICATION DURING THE DELAY. THEREFORE SINCE THE PHYSICIAN CONSIDERED THERE WAS A RISK TO THE PATIENT, THIS ISSUE WAS ASSESSED AS A REPORTABLE MALFUNCTION. THEREFORE, THE AWARENESS DATE WAS RESET TO (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138356 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1