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

Model Number FG540000

Device Problem Pacing Problem (1439)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrioventricular reciprocating tachycardia (avrt) / wolff-parkinson-white (wpw) syndrome ablation procedure with a carto 3 system.There was unwanted pacing on all channels.While pacing through the carto 3 system the system paced all channels instead of the selected channel on both the carto 3 system and the recording system.They tried pacing on a different channel, they reseeded the pacing cable and the issue persisted.They exchanged the pacing cable, and the issue was resolved, the case continued without any further incident.The medical team reported that they are pacing from the carto 3 system and not the recording system.The pacing leads were connected to the direct stimulator port as we cannot pace and ablate at the same time from map 1-2.The pacing stimulator being used during the procedure was a bloom2.The pacing was planned.There was pacing on all channels for a few beats before the physician stopped pacing due to seeing pacing signals across all the channels.The impedance cut-off value was not exceeded because it was below the 250 cutoff.The generator settings were temperature control mode of 40 watts and 60 degrees with impedance set to cut off above 250 ohms.Unwanted pacing is mdr-reportable.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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

On 6-mar-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrioventricular reciprocating tachycardia (avrt) / wolff-parkinson-white (wpw) syndrome ablation procedure with a carto 3 system.There was unwanted pacing on all channels.While pacing through the carto 3 system the system paced all channels instead of the selected channel on both the carto 3 system and the recording system.They tried pacing on a different channel, they reseeded the pacing cable and the issue persisted.They exchanged the pacing cable, and the issue was resolved, the case continued without any further incident.The medical team reported that they are pacing from the carto 3 system and not the recording system.Device evaluation details: the account used the same pacing cable when issue reoccurred.The user exchanged the pacing cable duplicate, and the issue was resolved.The user went back to the old pacing cable to verify the issue and the issue occurred again.The user exchanged the pacing cable duplicate again and the issue was resolved, the case was completed without any further incident.It was confirmed that a replacement pacing cable duplicate was provided to the customer under a work order.It was requested to send the defective pacing cable duplicate for investigation to device manufacturer.It was confirmed that the pacing cable duplicate was faulty and cause reported pacing issue.In additional, an investigation was initiated by device manufacturer to investigate the issue.Based on investigation results, the issue was not related to carto software.The system is ready for use.The history of customer complaints associated with this specific system was reviewed and it was found that after the pacing cable duplicate replacement the issue was not reported anymore.A manufacturing record evaluation was performed for the carto 3 system # 11267, 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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14197468
• MDR Text Key: 290531980
• Report Number: 2029046-2022-00880
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR.