BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 17909883 · Received October 10, 2023

    Report

    Report Number
    2029046-2023-02276
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D4. PRIMARY UDI NUMBER (B)(4) AND TO SECTION G4. PMA/ 510(K) K213264. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED. IT WAS REPORTED THAT WHEN THE OCTARAY CATHETER WAS INSERTED INTO THE PATIENT IT WAS DISPLAYED ON THE CARTO® 3 SYSTEM AS FLIPPING UPSIDE DOWN, HOWEVER, THE CALLER STATED THAT THEY CONFIRMED WITH X-RAY THAT THE OCTARAY CATHETER CAME OUT NORMALLY IN THE SHEATH. THEY REPLACED THE CABLE AND THE ISSUE PERSISTED. THEY REPLACED THE OCTARAY CATHETER WITH AN OPTRELL CATHETER AND THE PROCEDURE CONTINUED. THERE WERE NO VISUALIZATION ISSUES OR NOISE ISSUES FOR THE OPTRELL CATHETER. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED THAT THE ISSUE WAS RESOLVED AFTER REMOVING THE NON-CARTO DEVICE. THE SYSTEM IS READY FOR USE. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE PROVIDED DATA WAS ONLY THE BACKUP DATA AND IT IS NOT SUFFICIENT FOR INVESTIGATION. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR AND ASSOCIATED WITH CARTO SYSTEM # (B)(6) WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINT WAS FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 #(B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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

    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 A MAP SHIFT OCCURRED. IT WAS REPORTED THAT WHEN THE OCTARAY CATHETER WAS INSERTED INTO THE PATIENT IT WAS DISPLAYED ON THE CARTO® 3 SYSTEM AS FLIPPING UPSIDE DOWN, HOWEVER, THE CALLER STATED THAT THEY CONFIRMED WITH X-RAY THAT THE OCTARAY CATHETER CAME OUT NORMALLY IN THE SHEATH. THEY REPLACED THE CABLE AND THE ISSUE PERSISTED. THEY REPLACED THE OCTARAY CATHETER WITH AN OPTRELL CATHETER AND THE PROCEDURE CONTINUED. THERE WERE NO VISUALIZATION ISSUES OR NOISE ISSUES FOR THE OPTRELL CATHETER. THE CALLER STATED THAT THERE APPEARED TO BE A MAP SHIFT ON THE CARTO® 3 SYSTEM. THE MAP SHIFT MEDIAL FROM THE LESION SET. THERE WERE NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM, NO PATIENT MOVEMENT, AND NO CARDIOVERSION. THE PATCHES DID NOT MOVE, THERE WAS NO SHIFT IN FLUORO AND NO SHIFT IN RESPIRATIONS. NO TROUBLESHOOTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179813 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OCTA,LNG,48P,3-3-3-3-3,D-CURVE.| UNKNOWN RECORDING SYSTEM.| UNK_OPTRELL MAPPING CATHETER.