BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4885503 · Received July 1, 2015

    Report

    Report Number
    3008203003-2015-00048
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A NON-MDR REPORTABLE SYSTEM PERFORMANCE ISSUE OCCURRED; THE CONFIDENCE SOFTWARE FROZE WHILE RADIO FREQUENCY WAS BEING APPLIED. THIS IS A HIGHLY DETECTABLE ISSUE, HOWEVER, THIS CASE IS BEING MDR REPORTED BECAUSE THE PHYSICIAN CONTINUED ABLATION WITHOUT KNOWING THE POSITION OF THE CATHETER. ADDITIONAL INVESTIGATION INDICATED THAT THE PHYSICIAN CHOSE TO CONTINUE ABLATION WHEN THE CARTO MAPPING SYSTEM SOFTWARE FROZE. DURING THAT TIME, THE PHYSICIAN EXPRESSED CONCERN THAT ABLATION WAS UNINTENTIONALLY DELIVERED TO TISSUE AS HE WAS NOT AWARE OF THE CATHETER¿S LOCATION. THIS EVENT IS BEING REPORTED DUE TO THE RISK TO THE PATIENT INCURRED BY THIS DEVICE USAGE. THE CASE PROCEEDED WITHOUT PATIENT CONSEQUENCE. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. FSE VISITED THE ACCOUNT REGARDING THIS ISSUE. FSE WAS NOT ABLE TO DUPLICATE ANY ISSUE WITH THE SYSTEM, FSE PERFORMED ATP (ACCEPTANCE TEST PROCEDURE) TEST, AND VERIFIED SYSTEM OPERATION. SYSTEM PASSED ALL TEST. IT WAS IN SERVICE AND READY TO USE. AFTER FOLLOW UP THE CAS STATED THE ISSUE CONTINUED, AND CAS OPENED ANOTHER COMPLAINT ((B)(4)). FSE ORDERED A NEW WORKSTATION AND THE WORKSTATION WAS REPLACED. CAS REPORTED THAT THE FAULTY WORKSTATION WAS REIMAGED AND REMOVED FROM THE SITE. SYSTEM IS OPERATIONAL. HTC: THE ISSUE IS RELATED TO THE SW BUG # (B)(4) "CARTO APPLICATION FREEZE FOR A FEW SECONDS." HTC SENT A RECOMMENDED WORKAROUND TO FIELD TO AVOID THE FREEZING. THIS IS A KNOWN ISSUE, THEREFORE, NO NEED HTC INVESTIGATION OF THE WORKSTATION. THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH CARTO 3 SYSTEM # (B)(4) WAS REVIEWED. ONE OUT OF (B)(4) ADDITIONAL REPORTED COMPLAINTS MAY BE RELATED TO THE REPORTED ISSUE. THE DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A NON-MDR REPORTABLE SYSTEM PERFORMANCE ISSUE OCCURRED; THE CONFIDENSE SOFTWARE FROZE WHILE RADIO FREQUENCY WAS BEING APPLIED. THIS IS A HIGHLY DETECTABLE ISSUE, HOWEVER, THIS CASE IS BEING MDR REPORTED BECAUSE THE PHYSICIAN CONTINUED ABLATION WITHOUT KNOWING THE POSITION OF THE CATHETER. ADDITIONAL INVESTIGATION INDICATED THAT THE PHYSICIAN CHOSE TO CONTINUE ABLATION WHEN THE CARTO MAPPING SYSTEM SOFTWARE FROZE. DURING THAT TIME, THE PHYSICIAN EXPRESSED CONCERN THAT ABLATION WAS UNINTENTIONALLY DELIVERED TO TISSUE AS HE WAS NOT AWARE OF THE CATHETER¿S LOCATION. THIS EVENT IS BEING REPORTED DUE TO THE RISK TO THE PATIENT INCURRED BY THIS DEVICE USAGE. THE CASE PROCEEDED WITHOUT PATIENT CONSEQUENCE. THE CARTO IFU STATES THAT IN CASES IN WHICH THE CATHETER(S) ORIENTATION OR DEFLECTION CANNOT BE DETERMINED FROM THE VISUAL REPRESENTATION OF THE CATHETER ON THE CARTO® 3 SCREEN, THE USER IS ADVISED TO REFER TO THE FLUOROSCOPIC IMAGE OF THE CATHETER. BEFORE APPLYING RF ENERGY, VISUALLY VERIFY THE TIP POSITION OF THE MAPPING CATHETER IN RELATION TO THE VISUALIZED CATHETER IN THE MAP. A PHYSICIAN SHOULD USE COMMON CLINICAL PRACTICE, SUCH AS FLUOROSCOPY OR INSPECTION OF IC SIGNALS, TO VERIFY THE LOCATION OF THE CATHETERS THROUGHOUT THE PROCEDURE. FAILURE TO DO SO MIGHT RESULT IN INCORRECT PLACEMENT OF THE CATHETER. ALSO, AS IN ALL MAPPING PROCEDURES, ENSURE THAT THE LOCATION REFERENCE DOES NOT MOVE DURING THE STUDY. IF THE REFERENCE MOVES, CONTOUR DISPLAY MIGHT APPEAR IN AN INCORRECT POSITION, LEADING TO MISINTERPRETATION AND INCORRECT TARGET FOR ABLATION OR PERFORATION. THE PHYSICIAN APPEARS TO HAVE BEEN DEVIATED FROM THE RECOMMENDED BWI INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424582 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1