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

Model Number M-4800-01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6) year old, male, underwent an atrial flutter (afl) procedure with a carto 3 system and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.An ablation catheter that was already in the patient¿s heart was plugged into a reprocessed mapping cable which was already connected to the patient interface unit (piu).Upon connection, there were large amplitude spikes at about 100 ms and signal saturation was noticed throughout all electrocardiograms (ecg), electrograms (egm) and monitoring channels making it unable to see any ecg signal.In addition, there was a "current leakage" alert on the carto 3 system.The patient, who was moderately sedated, received an electric shock for six seconds when the catheter was connected to the cable.It was then noted that the patient became asystolic for approximately three seconds and then spontaneously went into atrial fibrillation.The issue ceased when the cable was detached from the catheter.The cable was replaced and the same catheter was reconnected to the new cable without any errors appearing.Hemodynamic support in the form of vasopressors for approximately 30 minutes was provided to the patient following the incident.The patient was cardioverted and the procedure was continued with no further issues with the patient.The patient also required an overnight stay that was not anticipated.The patient was reported to be in stable condition and was released the next day.The right atrium was about to be mapped and the patient had an existing dual chamber pacemaker that did not capture for a few seconds afterword and then reverted to magnet mode.It was examined afterwards and was found to be in working order.The physician believes there was current transfer from the piu through the ablation catheter.

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 products: coolflow pump (model# m-5491-02 serial# (b)(4)).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.Contact office and manufacturing site should reflect: (b)(4).Manufacturer's ref.No: (b)(4) event description continuation: the products involved were the ez steer thermocool sf nav catheter, c3 interface cable ¿ therapeutic, carto 3 system and stockert system.It is currently unknown which product contributed to the event and a complete investigation will be done to determine the causative device.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient, (b)(6), male, underwent an atrial flutter (afl) procedure with a carto 3 system and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.Field service engineer (fse) performed full functional test with focus on dc voltage and resistance tests.All tests passed with no issue.Fse could not duplicate any problem during testing.System is ready for use.Additional investigation was performed by the device manufacture to the cable and catheter which were involved in the issue.The reported issue was not duplicated while connecting the suspicious catheter extension cable and the original catheter to patient interface unit and checking it with the carto 3 application.The cable and catheter were found to have no effect on ecg signal quality.Proper isolation was found between the cable power lines and cable electrodes lines as well as between the catheter power lines and catheter electrodes lines.Neither cable nor catheter caused leakage current.The history of customer complaints associated with the carto 3 system were reviewed.There was not any additional complaints that may be related to the reported issue.Device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4588107
• MDR Text Key: 5453049
• Report Number: 3008203003-2015-00011
• 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
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• 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: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85