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

Catalog Number FG540000

Device Problems Signal Artifact/Noise (1036); Computer Software Problem (1112); Communication or Transmission Problem (2896)

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

Event Date 02/14/2024

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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a patient underwent an atrial flutter ablation procedure which included a carto® 3 system.On the 7th ablation, 2 sec in, there was a huge amount of noise interference, all signals lost (electrocardiogram (ecg) & intracardiac electrograms (egm)), though catheters still visible.Ablation stopped at 7sec.Coronary sinus (cs) signals recovered, but not surface ecg or map signals.They rebooted the workstation and the patient interface unit (piu) and when piu was off, surface ecg signal was ¿restored on bard¿.When piu was rebooted, the signal was gone again.They eventually turned off the piu, and had all signals restored.However, they were unable to ablate, as the pui was off.They had to change to a ¿df tc non-nav ablation catheter¿ in order to complete the procedure.There were never just flat lines.Either very noisy, or little blips, like all the ecg cables were not connected.There was no problem with the ecg input.They did not take photos of the carto error, or waveforms, while troubleshooting, or before shutting down.When they reopened the study after the case, they could get ablation graph details of the last lesion.Everything was shut down after the case, and then rebooted.Carto worked for the next case, which was also a flutter (minimal geo collection, mostly just lesions).Additional information received on 21-feb-2024 which indicated that during troubleshooting, the physician did not have any intact ecg signal available to monitor the patient heart rhythm.As such, this event was assessed as mdr reportable with an awareness date of 21-feb-2024.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter ablation procedure which included a carto® 3 system.On the 7th ablation, 2 sec in, there was a huge amount of noise interference, all signals lost (electrocardiogram (ecg) & intracardiac electrograms (egm)), though catheters still visible.Ablation stopped at 7sec.Coronary sinus (cs) signals recovered, but not surface ecg or map signals.They rebooted the workstation and the patient interface unit (piu) and when piu was off, surface ecg signal was ¿restored on bard¿.When piu was rebooted, the signal was gone again.They eventually turned off the piu, and had all signals restored.However, they were unable to ablate, as the pui was off.They had to change to a ¿df tc non-nav ablation catheter¿ in order to complete the procedure.There were never just flat lines.Either very noisy, or little blips, like all the ecg cables were not connected.There was no problem with the ecg input.They did not take photos of the carto error, or waveforms, while troubleshooting, or before shutting down.When they reopened the study after the case, they could get ablation graph details of the last lesion.Everything was shut down after the case, and then rebooted.Carto worked for the next case, which was also a flutter (minimal geo collection, mostly just lesions).Additional information received on 21-feb-2024 which indicated that during troubleshooting, the physician did not have any intact ecg signal available to monitor the patient heart rhythm.As such, this event was assessed as mdr reportable with an awareness date of 21-feb-2024.Hardware investigation details: the biosense webster inc.(bwi) field service engineer tried to contact account three times; however, no response was received.An investigation was initiated by the manufacturer.It was confirmed that the system displayed alert 1201 that caused to ecg signal loss.However, the root cause was not determined.It was also confirmed that the system worked fine during the next case.The problem was not duplicated since then.The complaint history of the system was reviewed, and no similar problems were found since the issue occurred.The system is ready for use.The history of customer complaints reported during the last year and associated with carto 3 system #34708 was reviewed.No similar additional complaint was found.A manufacturing record evaluation was performed for the carto 3 system #34708, and no internal actions 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 reference number: (b)(4).

Manufacturer Narrative

Additional information was received and it was noted that the manufacture date of the carto® 3 system is 17-jun-2018.Therefore, h4.Device manufacture date has been updated.Correction: full udi has been populated to field d4.Primary udi number.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18927572
• MDR Text Key: 338988665
• Report Number: 2029046-2024-00904
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2024

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 Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 05/16/2024; 06/17/2024
• Supplement Dates FDA Received: 06/12/2024; 07/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DF TC NON-NAV ABLATION CATHETER.; ECG TRUNK CABLE.; UNK GENERATOR.