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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 08/03/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported that there was intermittent loss of catheter visualization, and error 401: "map points cannot be acquired," on the carto® 3 system.The issue began in the middle of the procedure and occurred during and in between radiofrequency (rf) applications.To troubleshoot prior to calling, they exchanged the indifferent electrode, exited the study and resumed.They also exchanged the map cable.Once the study was reinitialized, the error and issue seemed to be resolved.However, a map shift was observed, with no error.The caller started a new map, and the case was continued without further issues.The shift was discovered after reloading the carto app and resuming the study.No errors were encountered.It was discovered by the physician who was identifying location of the his and the his catheter snapshot from earlier.The loss of visualization intermittently of all catheters, while on ablation and while off ablation.The approximate difference in catheter location before and after map shift was about 0.5cm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The patient was under monitored anesthesia care (mac) sedation, given that the bwi representative thought the shift occurred while they were reloading the app and not while they were in an active study.The study did prompt that there ¿could have been a map shift¿; however, it gave no errors to indicate a shift.The catheter visualization issue was assessed as not mdr reportable.The map shift with no error message, no patient movement/cardioversion was assessed as mdr reportable product malfunction.Such map shifts could potentially be caused by a system malfunction, and there is a potential risk to patient.

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 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigational analysis has been completed on 21-sep-2022.It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported that there was intermittent loss of catheter visualization, and error 401: "map points cannot be acquired," on the carto® 3 system.The issue began in the middle of the procedure and occurred during and in between radiofrequency (rf) applications.To troubleshoot prior to calling, they exchanged the indifferent electrode, exited the study and resumed.They also exchanged the map cable.Once the study was reinitialized, the error and issue seemed to be resolved.However, a map shift was observed, with no error.The caller started a new map, and the case was continued without further issues.Investigation details: the issue was investigated by the device manufacturer.It was found that the reported map shift was caused by patient movement.According to carto 3 instructions for use, (p.N.Ug-5400-0072h, rev.P02): "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated." the history of customer complaints reported during the last year associated with carto 3 system # 14616 was reviewed and one additional complaint similar to the reported issue was found.A manufacturing record evaluation (mre) was performed for the finished device number 14616 and no internal action related to the complaint was found during the review.Per the mre, the h4.Device manufacture date has been updated.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: 15325698
• MDR Text Key: 304983209
• Report Number: 2029046-2022-02050
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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