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

Model Number FG540000

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia ablation procedure using the carto® 3 system and a noise on all ecg signals occurred.It was reported that during the ventricular tachycardia ablation procedure the carto® 3 system which restarted by itself.It shut down and reopened again.Later, ¿error 7¿ appeared ("current leakage").Next, there was noise on unipolar signal with the smartablate on and noise on ecg body surface and on all ecgs during application.The case was completed with delay of around 30 minutes.There were no patient consequences.On 11/29/2019, additional information was received confirming the noise appeared on the bs ecg on both the carto® 3 system and recording system.During the event the physician did not have any ecg signals to monitor the patient's heart rate.In physician¿s opinion, the delay did not contribute to a death or serious injury to the patient.The customer¿s reported system (software) crash, the current leakage error and the procedure delay are to be considered non-mdr reportable since the potential risk that any of these could cause or contribute to a death or serious deterioration in state of health is remote.However, on 11/29/2019 bwi became aware of additional information indicating the physician had no other way of monitoring the patient¿s heart rate and reassessed the issue of noise on all ecgs to be an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent a ventricular tachycardia ablation procedure using the carto® 3 system and a noise on all ecg signals occurred.It was reported that during the ventricular tachycardia ablation procedure the carto® 3 system which restarted by itself.It shut down and reopened again.Later, ¿error 7¿ appeared ("current leakage").Next, there was noise on unipolar signal with the smartablate on and noise on ecg body surface and on all ecgs during application.The case was completed with delay of around 30 minutes.There were no patient consequences.On 11/29/2019, additional information was received confirming the noise appeared on the bs ecg on both the carto® 3 system and recording system.During the event the physician did not have any ecg signals to monitor the patient's heart rate.In physician¿s opinion, the delay did not contribute to a death or serious injury to the patient.The device evaluation details: the biosense webster inc.(bwi) field service engineer (fse) followed up the issues with account and was informed that after 3 cases the issue has not been duplicated but consider the issues experienced with the system are random and recurrent, it was agreed with local team to replace the patient interface unit (piu) to discard any hardware issue.The fse replaced the customer¿s piu and location pad (lp) kit with a new one and completed all required acceptance tests with success.System is ready for use.The replaced piu/lp kit was sent to the device manufacturer for investigation.It was determined that the customer¿s complaints of the system restarts, error 7, noise on the all ecg channels and lost ecg signals were confirmed.The loc rx card and dc/dc card found faulty and caused the piu to restart.On the loc rx card were found defective voltage regulators 5 v, and on the dc/dc card they found defective ethernet communication port.The both cards are repaired.The error 7, ecg noise and lost ecg signals issues were confirmed too.It caused by 2 failed ecg cards in the piu.On the ecg cards were found defective opto-switches.During investigation was found that all the failed ecg cards are related to old type of cards that were produced with old type of opto-switches.The opto-switches were replaced and cards were upgraded.The piu repaired and functioning correctly.A manufacturing record evaluation was performed for the system 10283, and no internal actions related to the reported complaint condition were identified.The ecg noise and lost signals issues are related to an internal corrective action.*correction: it was noticed that the concomitant products were inadvertently omitted from the 3500a initial mdr.The products have now been added to field d11.Concomitant med.Products.Manufacturer¿s ref # (b)(4).

• 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: 9501158
• MDR Text Key: 200011155
• Report Number: 2029046-2019-04045
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RECORDING SYSTEM; SMARTABLATE