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

Catalog 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 02/21/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred during the procedure even though the patches did not move.There were no errors displayed on the carto® 3 system.No patient movement, no cardioversion, and no metal were introduced.They created a new map and continued the procedure.It was also reported that maps synced together even though it was not selected to do so.The procedure continued.No adverse patient consequence was reported.It was also reported that sometimes when looking at the respiratory voltage, it would only show it for a specific section and not the entire map.They continued the procedure without resolution.The caller stated that a default template was in use.

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).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred during the procedure even though the patches did not move.There were no errors displayed on the carto® 3 system.No patient movement, no cardioversion, and no metal were introduced.They created a new map and continued the procedure.It was also reported that maps synced together even though it was not selected to do so.The procedure continued.No adverse patient consequence was reported.It was also reported that sometimes when looking at the respiratory voltage, it would only show it for a specific section and not the entire map.They continued the procedure without resolution.The caller stated that a default template was in use.Device evaluation details: an investigation was initiated by the manufacturer to investigate the issue.The data was requested for an investigation; however, no full data was available to investigate this case, only a backup.As a result, it was not possible to reproduce or analyze the issue.The root cause of the reported issue was not determined.The history of customer complaints reported during the last year and associated with carto 3 system with serial number (b)(6) was reviewed.No similar additional complaints were found.A manufacturing record evaluation was performed for the system 29340, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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: 18933743
• MDR Text Key: 338560288
• Report Number: 2029046-2024-00908
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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