MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

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.Concomitant product: smartablate generator (model# m-4900-07, serial# (b)(4)).(b)(4).

Event Description

This event was originally reported under the thermocool® smarttouch® bi-directional navigation catheter (mdr report# 9673241-2016-00114).It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a thermocool® smarttouch® bi-directional navigation catheter and suffered cardiac arrest, which required defibrillation.Irregular cardiac arrhythmia was noticed and the patient was induced with ventricular fibrillation with radiofrequency and rescued with a defibrillator.The patient did not require hospitalization due to the event.The patient has fully recovered.During the investigation, the carto 3 system was identified as possibly contributing to this event.Therefore on november 22, 2016, it was decided to also report this event under the carto 3 system.Once the investigation has been completed, a supplemental report will be submitted with the investigation conclusion to this event.

Manufacturer Narrative

Additional information was received on december 9, 2016.An error message was displayed as well as a loss of electrocardiogram signals was observed.The carto 3 system was operable during the display of the message and they were allowed to deliver radiofrequency energy.Epicardial ablation was used and was associated with high impedance values of greater than 300 ohms that they mitigated by shutting off the generator impedance cut off.This was the scenario associated with current leakage.Additional information was received on december 16, 2016.At the end of the procedure, intracardiac echocardiogram showed a trace stable effusion.The hardware (carto 3 system) investigation has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted manufacturer's ref.No: (b)(4).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a carto 3 system and suffered cardiac arrest, which required defibrillation.There was also a signal lost on the carto 3 system and the recording system.A current leakage error was also displayed.However, the physician was able to monitor patient¿s rhythm via defibrillator therefore the noise issue was not mdr reportable.The field service engineer (fse) visually inspected the system and observed damage on the map port of the patient interface unit (piu) of bent pins.Fse performed wet bath test with damaged backplane card.While ablating, error code 7 and pop-up window stating leakage current detected was displayed.Fse replaced the backplane card, performed wet bath and performed functional test per atp.Error code 7 - leakage current message was not displayed.Fse repeated several additional radiofrequency (rf) ablation tests, cycled power of piu, different carto 3 studies, all with no errors displayed.Fse followed up with the account after the repair.Bwi representative stated that the next three cases were performed without any issues.Issue was resolved, however the piu was replaced per physician request.Fse was informed by the bwi representative that the physician expressed concern of patients going into ventricular fibrillation.This was seen while delivering rf ablation.Piu was replaced to have device manufacturer perform analysis.Fse returned the defective backplane card into the old piu before uninstalling.Fse performed functional test following atp and all test passed.System is ready for use.Replaced piu was sent to the device manufacturer for analysis.The device manufacturer reported, the customer complaint was confirmed.Piu was tested and found inoperable due to the defective backplane card.There was found the damaged tvs diode d1000 which had very low impedance at one direction.This was a reason for the current leakage error and loss of electrocardiogram (ecg) signals.Replacement of the old revision damaged component resolved the problem.The faulty tvs in m1 ecg channel can generate dc voltage during ablation and cause the cardiac arrhythmia.The physician¿s improper workflow of not responding to system error 7 as instructed in the carto 3 system instructions for use, caused system failure, creating current leakage and the potential for induction of ventricular arrhythmia.During the system test, fse observed chest patch sensor error and no chest patches (yellow) were shown on the screen.Fse replaced the chest patch sensor cable, and the issue was resolved.Device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.The ecg signal loss/current leakage error issue is related to an internal corrective action.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6182928
• MDR Text Key: 62672913
• Report Number: 3008203003-2016-00046
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention