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

Catalog Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a carto® 3 system and a map shift issue occurred.They had a map shift without error.They then did the map again.There was a 5 minutes delay and the case completed.There was no patient consequence.On 8-feb-2024, additional information was received indicating the map shift occurred while ablating.The approximate difference in catheter location before and after map shift was 15mm.The system provided an error that they were outside the volume.The physician did not perform cardioversion and there was no patient movement felt by the problem.

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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a carto® 3 system and a map shift issue occurred.They had a map shift without error.They then did the map again.There was a 5 minutes delay and the case completed.There was no patient consequence.Device evaluation details: an investigation was initiated by the manufacturer to investigate the issue.It was found that the issue is related to system engineering (se) defect.The defect is being handled per defect management process.The history of customer complaints reported during the last year and associated with carto 3 system # 10320 was reviewed.No similar additional complaints were found.A manufacturing record evaluation was performed for system 10320, and no internal action 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 ref.# (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: 18823161
• MDR Text Key: 336793687
• Report Number: 2029046-2024-00704
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2010
• 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