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 02/27/2023

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 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 fibrillation (afib) and the carto 3 system workstation froze and displayed a message to restart the application.The medical team stated that after that error was displayed they had multiple map shifts.The station went back to the original map shift after two additional maps were created.The system was rebooted and the issue resolved.The procedure was completed.No patient consequences were reported.Software version 7.2.40.250 additional information: the issue occurred during mapping and between ablation points.No energy was being delivered.The difference in catheter location before and after the map shifts were 3-4 cm.Below are the two maps overlaid.No cardioversion, patient intubated and paralyzed.Patient did not move.Nor did table, image intensifiers, or c-arms.Software crash is not mdr-reportable.Map shift without patient movement/cardioversion/no error message is mdr-reportable.

Manufacturer Narrative

On 27-apr-2023, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) and the carto 3 system workstation froze and displayed a message to restart the application.The medical team stated that after that error was displayed they had multiple map shifts.The station went back to the original map shift after two additional maps were created.The system was rebooted and the issue resolved.The procedure was completed.No patient consequences were reported.Device evaluation details: field service engineer confirmed with cas that no cardioversion and the patient did not move during the procedure.According to company representative reported issue was not duplicated in following cases, and the system performs to specifications.The study data, which related to the reported issue, was exported from the system and it was sent to the device manufacturer for investigation.It was confirmed that the reported map shifts was caused by 2 reasons.First, a map shifts were caused by patient movement (despite it being reported that there was no patient movement prior to the map shift).Map shift due to a patient movement even if no error message present is a normal or expected response from the system.There was no system malfunction.Second, a map shift was caused by mapping with alternating metal levels at different heart areas.The system displayed a warning, but the user ignored this.The reported map shifts was related to user error.The system is operational.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.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16616941
• MDR Text Key: 312415987
• Report Number: 2029046-2023-00637
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• 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: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2012
• 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