BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3102505 · Received May 9, 2013

    Report

    Report Number
    3008203003-2013-00063
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE, THE CARTO 3 SYSTEM HAD A MAP SHIFT. ON THE NINTH ABLATION, THE THERMOCOOL SF NAVISTAR CATHETER DEVELOPED NOISY ECG'S AND THE BASELINE TEMPERATURE DROPPED FROM 36 DEGREES TO 30. THE NAVISTAR CABLES WERE CHANGED WITHOUT RESULT. THE NAVISTAR CATHETER WAS CHANGED AND THE BASELINE TEMPERATURE RETURNED TO 36 DEGREES AND THE NOISE DISAPPEARED. AT THIS POINT, IT WAS NOTICED THAT THE NEW NAVISTAR CATHETER LOCATION DID NOT MATCH THE PREVIOUS MAP WHEN THE CATHETER WAS PLACED AT THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) VALVE. A NEW MAP WAS CREATED AND THE CASE WAS CONTINUED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THERE WAS NO WARNING MESSAGE FROM THE CARTO 3 SYSTEM BEFORE THE MAP SHIFT. AFTER FOLLOW-UP, PER THE BWI FIELD REPRESENTATIVE THEY HAVE NOT HAD A MAP SHIFT SINCE THIS TIME. THE ACCOUNT DECLINED SERVICE AS THE ISSUE HAD NOT REOCCURRED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE, THE CARTO 3 SYSTEM HAD A MAP SHIFT. ON THE NINTH ABLATION, THE THERMOCOOL SF NAVISTAR CATHETER DEVELOPED NOISY ECG'S AND THE BASELINE TEMPERATURE DROPPED FROM 36 DEGREES TO 30. THE NAVISTAR CABLES WERE CHANGED WITHOUT RESULT. THE NAVISTAR CATHETER WAS CHANGED AND THE BASELINE TEMPERATURE RETURNED TO 36 DEGREES. AT THIS POINT, IT WAS NOTICED THAT THE NEW NAVISTAR CATHETER LOCATION DID NOT MATCH THE PREVIOUS MAP WHEN THE CATHETER WAS PLACED AT THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) VALVE. A NEW MAP WAS CREATED AND THE CASE WAS CONTINUED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THERE WAS NO WARNING MESSAGE FROM THE CARTO 3 SYSTEM BEFORE THE MAP SHIFT. THE FLUOROSCOPY WAS NOT MOVED. THERE WAS NO CARDIOVERSION PERFORMED. THE PATIENT DID NOT MOVE PRIOR TO THE SHIFT. THE REFERENCE PATCH DID NOT MOVE NOR GET LOOSE BEFORE THE MAP SHIFT. ONLY THE MAPPING CATHETER WAS USED AND IT SHIFTED APPROXIMATELY 1 CM PER THE PHYSICIANS ASSESSMENT. THE MAP SHIFT WAS NOT CORRECTED DURING THE CASE, THE AREA WAS REMAPPED AND THEN RF WAS APPLIED. WHEN ATTEMPTING THE NINTH RF LESION, THE GENERATOR WOULD NOT COME ON DUE TO THE LOW TEMPERATURE. THERE WAS NO ABLATION BEING DELIVERED AT THIS TEMPERATURE. THE GENERATOR WAS IN POWER MODE. A LOW TEMPERATURE WARNING MESSAGE APPEARED. THE NOISE OCCURRED ON THE DISTAL ABLATION CHANNEL ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM AT THE SAME TIME. THEY WERE UNABLE TO DISTINGUISH THESE SIGNALS. THE NOISE ISSUE DISAPPEARED AFTER THE CATHETER WAS REPLACED. SINCE THERE WAS NO WARNING MESSAGE FROM THE CARTO 3 SYSTEM BEFORE THE MAPSHIFT, THIS IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(6) 2013 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204186 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1