BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO XP SYSTEM

    MDR report key: 1884340 · Received October 27, 2010

    Report

    Report Number
    9681484-2010-00021
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. BWI CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER; MODEL #: D-1197-17-S; LOT #.: 15219285M. MANUFACTURER'S REF. NO.: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING THE PROCEDURE THE ECG SIGNALS (BS AND IC) DISAPPEARED ON THE CARTO SYSTEM. PIU POWER LIGHT WAS NO LONGER ON. BIOSENSE WEBSTER FIELD SERVICE ENGINEER FOUND A DEFECTIVE PIU POWER CABLE. THE CABLE WAS REPLACED. SYSTEM IS TESTED AND READY FOR USE. IN ADDITION, THE DEVICE HISTORY REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VT IDIOPATHIC PROCEDURE, AFTER DEFIBRILLATING A PATIENT, THE ECG SIGNALS (THE BS AND IC SIGNALS DISAPPEARED ON BOTH CARTO SYSTEM AND THE RECORDING SYSTEM. THE USER CHANGED THE CATHETER CABLE AND THE CATHETER WITHOUT RESOLUTION. THE USER FURTHER STATED THAT AFTER THE CATHETER CHANGE, SIGNALS RETURNED BUT ONLY INTERMITTENTLY AND WOULD DISAPPEAR AGAIN AFTER PACING (THE PACING WAS SCHEDULED/ NON-EMERGENCY PACING. THE PHYSICIAN WAS ATTEMPTING TO PACEMAP A VT). AFTER EXTENSIVE TROUBLE-SHOOTING, THE PIU WAS CHANGED AND THIS SEEMED TO INITIALLY RESOLVE THE ISSUE UNTIL THE USER BEGAN APPLYING ENERGY, THE SIGNALS DISAPPEARED AGAIN. THE USER NOTED A FLICKERING GREEN LIGHT ON THE FRONT OF THE PIU AND IT WAS DETERMINED THAT THE PIU POWER CABLE COULD POSSIBLY BE AT FAULT, AND WAS RECOMMENDED TO BE CHANGED. THE USER CHANGED THE PIU POWER CABLE AND THE FO CABLE, AS WELL AS REBOOTED THE SYSTEM AGAIN. THE PIU POWER LIGHT WAS NO LONGER ON. THE PHYSICIAN DID NOT ALLOW THE BWI REPRESENTATIVE PRESENT DURING THE CASE TO FURTHER CHECK FOR ANY OTHER SOLUTIONS. THE PHYSICIAN CONTINUED THE CASE WITHOUT THE USE OF CARTO AND COMPLETED THE PROCEDURE BY UTILIZING ONLY THE RECORDING SYSTEM FOR TRACINGS AND FLUOROSCOPY FOR CATHETER LOCATION. THE PHYSICIAN WAS NOT ABLATING AND PACING AT THE SAME TIME. THE PACING WAS DONE THROUGH THE PACING PORTS AND UTILIZING THE BLOOM STIMULATOR FOR PACING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO XP SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1