MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00J

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2015

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and a signal loss occurred.The ablation catheter was not displayed on the carto 3 when the catheter was inserted in to the cardiac cavity.Patch #6 was showing the metallic interference was a little high with a metal value displayed of about 25.The system was far away however the issue continued.The metallic interference then soared with a metal value displayed of about 60 and did not return to a normal value when the location pad was moved.Then the electrical potentials were not displayed on both the carto 3 and the lab.The screw of the location pad was retightened and the patient interface unit (piu) was rebooted but the issue continued.The patch unit was changed and rebooted and the piu initialization was only cycling steps 1 to 2 of 3.The issue was resolved by changing the piu, the location pad and the workstation.The procedure was then completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the available information, this event has been conservatively assessed as mdr reportable since it is unknown if the signal loss occurred on all the channels, including the 12 leads of body surface electrocardiograms (ecg) and all intracardiac ecg and it is also unknown if any ecg signal was available for the physician to monitor the patient's heart rhythm.Lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can cause potential patient injury.The other issues of no visualization, metal interference and communication issue with the piu are not mdr reportable as these issues are highly detectable and the potential that it may cause or contribute to a death, serious injury or significant adverse event is remote.

Manufacturer Narrative

After the initial report was submitted additional information was received on january 6, 2016 that the signal loss was only on the intracardiac signals of the ablation catheter.Thus this event has been reassessed as not mdr reportable because the patient's heart rhythm is still visible to the operator therefore the patient risk is low.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a signal loss occurred.After the initial report was submitted, additional information was received that the signal loss was only on the intracardiac signals of the ablation catheter.Thus this event has been reassessed as not mdr reportable because the patient's heart rhythm is still visible to the operator therefore the patient risk is low.System was sent to sukagawa repair center and the problem could not be duplicated.System is in order.In addition, the complaints after this event associated with this specific system was reviewed as well and there was not any additional complaint related to the reported issue.The 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: SIMILAR DEVICE FG540000, 510K # K042999
• 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 ; 9497893837
• MDR Report Key: 5333266
• MDR Text Key: 35076541
• Report Number: 3008203003-2015-00102
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-5400-00J
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/28/2016; 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1