BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3232879 · Received July 18, 2013

    Report

    Report Number
    3008203003-2013-00091
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED CARTO WAS DISPLAYING METAL INTERFERENCE ON PATCH ONE. METAL VALUE OF PATCH 1 WAS 20. IT WAS SUGGESTED TO THE CUSTOMER TO RAISE THE TABLE AND CHECK FOR METAL AND PATCH LOCATION. THE REF PATCH UNIT WAS RESEATED AND THE ISSUE REMAINED. IT WAS ADVISED TO THE CUSTOMER TO SWITCH THE SENOR CABLES IN REF PATCH UNIT AND NOW PATCH 4 IS 20. ISSUE WAS NOT RESOLVED. CUSTOMER DID NOT HAVE A NEW REF PATCH CABLE AVAILABLE. THE CASE WAS CANCELLED. ADDITIONAL INFORMATION PROVIDED STATED THE PATIENT WAS INTUBATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE MALFUNCTION. DUE TO THIS, THIS IS NOW A MDR REPORTABLE EVENT. THE INTUBATION TIME WAS PROLONGED DUE TO THE MALFUNCTION. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES. AFTER UNIT EVALUATION IT WAS DETERMINED THE ISSUE WAS DUE TO THE DEFECTIVE GREEN BACK PATCH CABLE. THE ISSUE WAS RESOLVED AFTER THE BACK PATCH CABLE WAS REPLACED. CUSTOMER¿S COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED CARTO WAS DISPLAYING METAL INTERFERENCE ON PATCH ONE. METAL VALUE OF PATCH 1 WAS 20. IT WAS SUGGESTED TO THE CUSTOMER TO RAISE THE TABLE AND CHECK FOR METAL AND PATCH LOCATION. THE REF PATCH UNIT WAS RESEATED AND THE ISSUE REMAINED. IT WAS ADVISED TO THE CUSTOMER TO SWITCH THE SENOR CABLES IN REF PATCH UNIT AND NOW PATCH 4 IS 20. ISSUE WAS NOT RESOLVED. CUSTOMER DID NOT HAVE A NEW REF PATCH CABLE AVAILABLE. THE CASE WAS CANCELLED. ADDITIONAL INFORMATION PROVIDED STATED THE PATIENT WAS INTUBATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE MALFUNCTION. DUE TO THIS, THIS IS NOW A MDR REPORTABLE EVENT. THE INTUBATION TIME WAS PROLONGED DUE TO THE MALFUNCTION. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335133 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1