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

Model Number M-5830-01

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

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.Contact office and manufacturing site should reflect: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 rmt system and there was a signal issue which the physician was unable to monitor the patient'a heart rhythm.During the procedure, the ecg signal disappeared from the screen.The pentaray catheter was changed for a lasso catheter.The ecg was then fine.However, there was no signal for the lasso catheter.The lasso catheter was disconnected and when reconnected a burst of noise appeared.The procedure was prolonged for an extra hour.However, it was completed with no patient consequence.Additional clarification was received on the event.When the problem occurred, there was no ecg available for the physician to monitor the patient's heart rhythm.For this procedure, the delay did not cause any potential risk to the patient.The delay was assessed as not reportable as there was no risk to the patient as a result of the procedure delay.The signal issue was assessed as reportable as the patient's heart rhythm was not visible to the physician.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 rmt system.It was reported that during the procedure when the pentaray catheter was in use, the intracardiac (ic) and body surface (bs) ecg signals disappeared on the carto 3 rmt system and the ep system.The customer replaced the pentaray catheter with the lasso catheter, and as a result, the problem was solved.It was also reported that right after replacement of the pentaray catheter with the lasso catheter, the lasso¿s bipolar signals could not be seen on the monitor.The issue was resolved by rebooting the system.It was reported that after the system reboot, the burst of noises were observed.The procedure was completed in a conventional way.The biosense webster field service engineer advised the biosense webster field representative to check all connections, set up the cables, and use only the new cables from the box for the next procedure.The biosense webster field representative reported that they replaced the eco dongle, bs ecg and the ablation adapter cables and the problem was resolved.The system is operational.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO 3 RMT 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 ; 9497893837
• MDR Report Key: 5244909
• MDR Text Key: 32217173
• Report Number: 3008203003-2015-00094
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090017
• 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: 11/05/2015

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: M-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1