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); Radio Signal Problem (1511); Device Displays Incorrect Message (2591)

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

Event Date 03/17/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a atrial fibrillation (afib) procedure with a carto 3 system and the physician did not have any ecg signal available to monitor the patient's heart rhythm.The issue occurred during use.The patient was under general anesthesia for two hours.A transseptal puncture had been performed.They were getting a current leakage error when the smart touch catheter was connected.They were also getting noise saturation on all of the intracardiac and surface electrograms on both the carto 3 system and the recording system.Changing out the catheter cable and the catheter did not resolve the issue.They also rebooted the system which also did not resolve the issue.Disconnecting the catheter from the cable did not resolve the issue.They connected another catheter cable and the issue reoccurred.They disconnected all of the catheter cables from the patient interface unit (piu), checked the ports for damage and rebooted the entire system.After the system fully initialized, the catheters were reconnected.This did not resolve the issue.The procedure was cancelled.The physician did not consider cancelling the procedure caused a potential risk to this patient.The patient did not require extended hospitalization.Since the physician did not consider cancelling the procedure caused a potential risk to the patient, the procedure cancellation was assessed as not reportable.The physician not having at least one ecg signal available to monitor the patient's heart rhythm was assessed as reportable.

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

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and the physician did not have any ecg signal available to monitor the patient¿s heart rhythm.It was reported that they are got a current leakage error when the smart touch catheter was connected.The bwi field service engineer investigated the issue at the site and confirmed in the study log files that the error was for 105(map: catheter sensor error) was logged.The bwi field service engineer confirmed that the issue was resolved by a catheter replacement.The customer also reported that the noise saturation was visible on all of the intracardiac and body surface (bs) electrograms.Changing out the catheter cable and the catheter as well as rebooting the system prior to calling did not resolve the issue.The customer disconnected all of the catheter cables from the piu, checked the ports for damage and rebooted the entire system.After the system fully initialized the catheters were reconnected.This did not resolve the issue.The bwi field service engineer investigated the issues at the site and confirmed in the study log files that the errors 1201(ecg limb lead disconnection) and error 7(leakage current detected on piu rl input) were logged.The bwi field service engineer explained to the lab manager and staff that the error 7 and error 1201 were related to a defective bs ecg trunk cable and bs-ecg lead cables.The bwi field service engineer replaced all body surface (bs) ecg cables.The bwi field service engineer supported the next atrial fibrillation procedure.None of the reported issues reoccurred.Also, no other issues occurred.System was ready for use.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 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: 4689685
• MDR Text Key: 5670621
• Report Number: 3008203003-2015-00021
• 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: 03/17/2015

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-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1