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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Computer Operating System Problem (2898)

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

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.While performing a re-map on the carto 3 system during the procedure, it was noticed that the map had shifted by about 3-4mm.There were no noted errors displayed on the carto 3 system, and there was no patient movement.It was reported that the issue may have been caused by the fluoro system being too close to the carto 3 system, but they could not confirm this.The veins had already been isolated, and the procedure continued.No patient consequences were reported.There was no error was provided.The physician noticed the shift when we were remapping after our ablation.The difference in catheter location was about 2-3 millimeters.There was no movement from the patient occurred nor did the physician perform a cardioversion.It was also reported that "one of the usb ports on the computer is not working.Throughout the procedure the keys on the keyboard would only intermittently respond.The medical team also noted that the keyboard was connected to the first front usb port on the workstation.The procedure continued with the issue intermittently persisting.After the procedure completed, the medical team replaced they keyboard and mouse, without resolution.It was also noted that when connecting a usb drive to the same usb port, it was not recognized on the carto 3 system.The workstation was rebooted, and the issue seems to have resolved for now.Software bug is not mdr-reportable.Map shift is mdr-reportable.

Manufacturer Narrative

On 18-aug-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.Device evaluation details: the data was requested for investigation, but no data related to the issue was not provided, according to company representative the data is no longer available.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported map shift issue was not determined.A manufacturing record evaluation was performed for the carto 3 system # (b)(6), 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 ; 646591-798
• MDR Report Key: 14485067
• MDR Text Key: 294533688
• Report Number: 2029046-2022-01115
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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