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

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and a noise issue occurred.It was reported that the carto 3 system and recording system were displaying electrocardiogram (ecg) noise on all channels.The noise appears when the ablation catheter is inserted into the body.There was an error message on the carto 3 system stating that a limb lead is disconnected.When the ablation catheter is withdrawn from the body the error disappears and the noise is gone.As soon as the ablation catheter is reinserted into the patient the noise and error message reappear.The ablation cable has been replaced without resolution.The catheter has been replaced without resolution.The 4 limb lead connection was checked and secure.The impedance was around 120 and reducing during ablation.Additional troubleshooting could not be done as the procedure was continuing.The procedure was continued with noise on ecg.There was no patient consequence.Upon request additional information was received on the event.The impedance cutoff value was never exceeded, ablation was normal and the procedure was able to be completed.Settings during the event include: power mode using the sf catheter.The temperature and power cutoffs were not exceeded.The physician did not have any ecg signal available to monitor patient¿s heart rhythm while the ablation catheter was connected.Pressures and heart movement were monitored using ultrasound during the procedure.This is indicative of a reportable event, as there was no ecg signal available to monitor the patient¿s heart rhythm.

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).

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and a noise issue occurred.Field service engineer (fse) attempted to duplicate issue with wet bath and electrocardiogram (ecg) simulator.The issue was not duplicated.Fse observed a case.The noise issue was not duplicated again.Bwi representative also tested system with catheter used in complaint case and did not succeed to reproduce issue.Fse left replacement ecg cables at account.System is operational.The history of customer complaints associated with this carto 3 system was reviewed.One additional reported complaint 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: shahe garabedian ; 9098397362
• MDR Report Key: 4781291
• MDR Text Key: 5859039
• Report Number: 3008203003-2015-00033
• 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: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1