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

Model Number FG-5400-00M

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Complete Heart Block (2627)

Event Date 05/17/2016

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.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system and suffered a heart block requiring cardiac massage.During the procedure, when the decanav¿ electrophysiology catheter was connected to the 20 pole a socket, a leakage error occurred.Subsequently, all channels connected to the carto 3 system displayed ¿n/a¿.Physician was unable to pace through catheters connected to the carto 3 system.Signal loss was observed on all ecg channels on the carto 3 system.Body surface ecg signal was available for the physician to monitor the cardiac rhythm.Pacing was planned.Pacing leads were connected to the primary pacing port.Carto did not allow pacing and ablating at the same time.Pacing stimulator manufacturer was fukuda denshi.This event was originally assessed as not mdr reportable because the potential that these issues could cause or contribute to a death, serious injury, or other significant adverse event is remote.On february 1, 2017 additional information was received that while troubleshooting for the issue above with the catheter in the cardiac cavity, an atrioventricular block (av) occurred.Since the carto was unable to pace, emergency cardiac massage was performed, which resolved the av block.Carto cable was changed and the system issue resolved.There is no information regarding extended hospitalization.Patient fully recovered.It was noted that the catheter shaft likely bumped the av node.It was noted that although there was no relationship between the av block and the carto 3 system issue, treatment for the av block was delayed.Physician¿s opinion regarding the cause of the adverse event is that it was related to a bwi product malfunction and procedure.The awareness date was reset to february 1, 2017, because that is when information was received that there was an injury during trouble shooting.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system and suffered a heart block requiring cardiac massage.During the procedure, when the decanav¿ electrophysiology catheter was connected to the 20 pole a socket, a leakage error occurred.Subsequently, all channels connected to the carto 3 system displayed ¿n/a¿.Physician was unable to pace through catheters connected to the carto 3 system.Signal loss was observed on all ecg channels on the carto 3 system.Body surface ecg signal was available for the physician to monitor the cardiac rhythm.The leakage error problem was reproduced.The catheter¿s cable was found faulty and was replaced.The issue resolved.It was also reported that the user did not require atp tests as the issue was related to the cable.It was reported that the system is operational.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6360858
• MDR Text Key: 68401915
• Report Number: 3008203003-2017-00008
• 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
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-5400-00M
• Device Catalogue Number: FG540000M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention