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

Model Number M-4800-01

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a carto 3 system.It is reported that there was a pacing artifact on the mapping catheter while pacing from coronary sinus (cs) catheter.The mapping catheter icon appeared to be pacing from m-3 while also pacing from the cs catheter.This issue only occurred while ablating.The procedure continued and was completed with this issue.There was no patient consequence.Upon clarification, pacing and ablating were allowed at the same time but not from the same electrode.Pacing was from the cs catheter only.The pacing was planned and there was no unwanted pacing.However, during the procedure, they were unable to delineate which catheter was pacing besides the cs catheter as the mapping catheter was reflecting pacing along with the cs catheter.The issue on the mapping catheter was not noise.A bloom stimulator was used during the procedure.The patient interface unit (piu) was switched to another one to test this issue and the same issue occurred.Furthermore, after some troubleshooting, it was stated that the piu does not have the direct pacing ecg cards ((b)(4)).Therefore, since they were unable to delineate if the mapping catheter was also pacing, this issue is indicative of a reportable event.

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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial flutter (afl) procedure with a carto 3 system.It is reported that there was a pacing artifact on the mapping catheter while pacing from coronary sinus (cs) catheter.The mapping catheter icon appeared to be pacing from m-3 while also pacing from the cs catheter.This issue only occurred while ablating.Upon clarification, pacing and ablating were allowed at the same time but not from the same electrode.Pacing was from the cs catheter only.The pacing was planned and there was no unwanted pacing.However, during the procedure, they were unable to delineate which catheter was pacing besides the cs catheter as the mapping catheter was reflecting pacing along with the cs catheter.When switching pacing channels from proximal to distal, there is a ~5 second delay before complete switch.Issue was investigated by device manufacturer.Issue is related to bug 15136/26903 - change to stimulation routing during initialization might cause delay of pacing.In some cases, when stimulation routing is changed during initialization, there is a delay of approximately 30 seconds before the pacing output is transferred to the patient.User must wait for approximately 30 seconds, or change the stimulation routing before or after initialization.This bug is included in all rn since v1.1.2 field service expert performed the quick pace upgrade (ecg 162 card was replaced) and performed ep out test, pacing and functional test (see atp/pm activity).All tests passed.The history of customer complaints associated with carto 3 system # 11704 was reviewed.1 out of 6 additional reported complaints may be related to the reported issue.A 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4282389
• MDR Text Key: 5297682
• Report Number: 3008203003-2014-00078
• 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: 10/29/2014

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: 10/29/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1