MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Computer Software Problem (1112); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation details: field service engineer performed troubleshooting onsite and was unable to replicate the issue with account 12 lead and field service engineer electrocardiogram testing cable.Field service engineer tested the system per the acceptance testing procedure, and all requirements passed.The system is functioning as expected and is ready for use.Non-manufacturing related potential cause has been identified, therefore no manufacturing record evaluation is required.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that during an atrial fibrillation (afib) ablation procedure, the carto(r) 3 system had error 1201 ecg (electrocardiogram) lead limb disconnection as well as a 19 failure in the patient interface unit (piu) ecg1 cart bit intermittently.The disposable limb lead patches were replaced, the electrocardiogram (ecg) cable was reseated and the patient interface unit was rebooted; however, the issue did not resolve.The patient interface unit and workstation were rebooted but the issue remained.The 12 lead body surface cable was replaced, and the issue remained.Reminder of the procedure was aborted.No ablation therapy could be performed.The physician was able to monitor patient's heart rhythm through the anestesia ecg monitor at all time.The patient was under general anesthesia for 1 hour and 50 minutes.No transseptal puncture was done prior to the case cancellation.The physician did not consider that cancelling the procedure represented an increased risk to the patient.There was no exacerbation of patient's disease.No additional intervention nor prolonged hospitalization were required.The ecg lead limb disconnection is not mdr-reportable.The piu 19 issue is not mdr-reportable.However, the absence of treatment is mdr-reportable.

Manufacturer Narrative

It was reported that during an atrial fibrillation (afib) ablation procedure, the carto® 3 system wherein a procedure cancellation occurred as the carto® 3 system had error 1201 ecg (electrocardiogram) lead limb disconnection as well as a 19 failure in the patient interface unit (piu) ecg1 cart bit intermittently.The physician did not consider that cancelling the procedure represented an increased risk to the patient.There was no exacerbation of patient¿s disease.No additional intervention nor prolonged hospitalization were required.Device evaluation details: additional investigation was performed as the issue was further analyzed by the device manufacturer.The issue was investigated by the device manufacturer.Based on the study data analysis, it was confirmed that the error 19 occurred twice, each time about 10-15 second until the error disappeared.After that the error didn¿t appear again.It was also confirmed that the error 1201 appeared much later than the error 19 and regardless of error 19.The root cause for error 1201 cannot be determined.Also, the field service engineer (fse) didn't find any problem during the system check on site.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.System is operational.The history of customer complaints reported during the last year associated with carto 3 system # 13184 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 13184, and no internal action related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Manufacturer's ref # (b)(4) on (b)(6)2021, during an internal review of the reported event, it was determined that the reported event of "absence of treatment" is to be considered a non-serious patient event and not mdr reportable since the physician did not consider that cancelling the procedure (absence of treatment) represented an increased risk to the patient.There was no exacerbation of patient¿s disease.No additional intervention nor prolonged hospitalization were required.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11305448
• MDR Text Key: 231210721
• Report Number: 2029046-2021-00148
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

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: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/14/2021; 05/27/2021
• Supplement Dates FDA Received: 04/09/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ECG CABLE; UNSPECIFIED ECG CABLE
• Patient Outcome(s): Other