BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 18490387 · Received January 10, 2024

    Report

    Report Number
    2029046-2024-00145
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WERE ERRATIC TEMPERATURE READINGS ON THE NGEN GENERATOR WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). CALLER DISCONNECTED THE CATHETER CABLE FROM THE PIU AND THEY NOTICED SOME WATER IN THE CONNECTOR OF THE CABLE AND THE PORT ON THE PIU. THE CABLE WAS REPLACED AND THERE WERE NO TEMPERATURE READINGS ON THE NGEN GENERATOR. WHEN THE CABLE WAS DISCONNECTED FROM THE PIU, THEY NOTICED BLACK CHAR ON THE INSIDE OF THE CONNECTOR AND THE INSIDE OF THE PORT. CALLER SWAPPED OUT THE PIU AND THE LOCATION PAD AND CONTINUED THE PROCEDURE. CALLER CONFIRMED THERE WAS SOME "MOISTURE" VISIBLE IN 20 POLE B PORT ON THE PIU. CALLER STATED IT APPEARED WHEN FLUSHING THE SMARTABLATE TUBING, THE PORT ON THE TUBING WAS FACING THE PIU AND IT MAY HAVE CAUSED SOME WATER DAMAGE. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED BY THE FIELD SERVICE ENGINEER (FSE) THAT THE STAFF MEMBER ACCIDENTALLY PURGED THE PUMP INTO THE FACE OF THE PATIENT INTERFACE UNIT (PIU) CAUSING WATER DAMAGE. THE DAMAGED PIU WAS REPLACED WITH ANOTHER ONE THAT WAS DELIVERED TO THE ACCOUNT. THE FAULTY PIU WAS REQUESTED FOR INVESTIGATION BUT THE COSTUMER REJECTED THE SERVICE AND DIDN'T WANT TO SEND IT FOR INVESTIGATION. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR AND ASSOCIATED WITH CARTO 3 SYSTEM # (B)(6) WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR SYSTEM (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: ON 30-SEP-2024, IT WAS NOTICED THE INCORRECT PMA/ 510(K) NUMBER OF ¿K133916¿ WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT UNDER FIELD G4. THE CORRECT NUMBER HAS NOW BEEN ADDED ¿K213264¿. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND THEY NOTICED BLACK CHAR ON THE INSIDE OF THE CONNECTOR AND THE INSIDE OF THE PORT. IT WAS REPORTED THAT THERE WERE ERRATIC TEMPERATURE READINGS ON THE NGEN GENERATOR WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). CALLER DISCONNECTED THE CATHETER CABLE FROM THE PIU AND THEY NOTICED SOME WATER IN THE CONNECTOR OF THE CABLE AND THE PORT ON THE PIU. THE CABLE WAS REPLACED AND THERE WERE NO TEMPERATURE READINGS ON THE NGEN GENERATOR. WHEN THE CABLE WAS DISCONNECTED FROM THE PIU, THEY NOTICED BLACK CHAR ON THE INSIDE OF THE CONNECTOR AND THE INSIDE OF THE PORT. CALLER SWAPPED OUT THE PIU AND THE LOCATION PAD AND CONTINUED THE PROCEDURE. CALLER CONFIRMED THERE WAS SOME "MOISTURE" VISIBLE IN 20 POLE B PORT ON THE PIU. CALLER STATED IT APPEARED WHEN FLUSHING THE SMARTABLATE TUBING, THE PORT ON THE TUBING WAS FACING THE PIU AND IT MAY HAVE CAUSED SOME WATER DAMAGE. THE ABLATION CATHETER WAS NEVER USED FOR ABLATION. ERRATIC TEMPERATURES WERE NOTICED WHILE IT WAS OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730820 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN RF GENERATOR, US.| THMCL SMTCH SF BID, TC, F-J.| UNK_SMARTABLATE PUMP TUBING.