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

Model Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an afib - paroxysmal procedure with a carto® 3 system and a map shift issue occurred.It was reported that when ablation was started in the left atrium, there was a map shift noted of about 8mm.No error was provided.While burning a roof line in the left atrium, the physician noticed the contact force vector pointed vertical while the fam shell indicated that they were not on the roof.The difference in catheter location before and after map shift was approximately 5mm difference.The procedure was continued with the issue.There was no patient movement or cardioversion performed.No adverse patient consequence was reported.The map shift issue was assessed as a mdr reportable product malfunction.

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

On 17-apr-2023, based on the investigation performed by the device manufacturer, the previously reported map shift, no error message issue was caused by a shift in anatomical structure due to respiratory mode change which leads to map shifts.As such, this event is no longer considered mdr reportable.However, since it has already been reported to fda, any additional updates received will continue to be reported.The hardware investigation was completed on 27-apr-2023.The biosense webster inc.(bwi) field service engineer (fse) tested the system and all atp tests passed.System is good for use.The issue was investigated by the device manufacturer.It was found that the map shift was caused by the change in respiration mode.The change of the respiration frequency and volume resulted in a real shift of the heart as the diaphragm (on which the heart is supported) average location was changed, it was shifted lower towards the legs.This was reflected at the cs location change.System is operational.Conclusion: map shift originated from a change in respiration mode.A manufacturing record evaluation (mre) was performed for the finished device 29079 number, and no internal acitons related to the complaint was found during the review.Based on 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16632968
• MDR Text Key: 312413962
• Report Number: 2029046-2023-00660
• 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,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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