MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problems Pacing Problem (1439); Appropriate Term/Code Not Available (3191)

Patient Problem Arrhythmia (1721)

Event Date 10/18/2022

Event Type  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.Initial reporter phone: (b)(6).(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto® 3 system and unwanted pacing occurred.It was reported there was a spike was entered automatically 2000 ms after pacing from a non-bwi cs catheter.The procedure was continued to be successfully completed without patients¿ consequence.The pacing stimulation was conducted with the cs catheter that was made by another company.It was planned pacing.The physician commented that the pacing spike that occurred 2000 msec after the pacing stimulation induced extrasystoles and atrial fibrillation occurred.The pacing lead of the cs catheter was connected to the primary pacing port of the carto3 piu.Ablation was not performed at the same time as pacing from map catheter ch.1 -2.A fukuda denshi pacing co., ltd stimulator was used.Arrhythmia will be coded conservatively as they report that ¿pacing spike that occurred 2000 msec after the pacing stimulation induced extrasystoles and atrial fibrillation occurred¿ this is not considered to be a patient adverse event base on the information available.Follow up has been request should additional information become available this complaint will be reassessed accordingly.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto® 3 system and unwanted pacing occurred.It was reported there was a spike was entered automatically 2000 ms after pacing from a non-bwi cs catheter.The procedure was continued to be successfully completed without patients¿ consequence.The pacing stimulation was conducted with the cs catheter that was made by another company.It was planned pacing.The physician commented that the pacing spike that occurred 2000 msec after the pacing stimulation induced extrasystoles and atrial fibrillation occurred.The pacing lead of the cs catheter was connected to the primary pacing port of the carto3 piu.Ablation was not performed at the same time as pacing from map catheter ch.1 -2.A fukuda denshi pacing co., ltd stimulator was used.Arrhythmia will be coded conservatively as they report that ¿pacing spike that occurred 2000 msec after the pacing stimulation induced extrasystoles and atrial fibrillation occurred¿ this is not considered to be a patient adverse event base on the information available.Device evaluation details: the biosense webster inc (bwi) field service engineer (fse) confirmed that there were no jumper pins on site and instructed them to check with agent.It was reported there was no reproducibility at present, and normal operation of the system has been verified, so it will be closed.In addition, the issue was investigated by the device manufacturer under investigation request.The issue was not reproduced in the manufacturer lab.No additional investigation can be performed as the data related to the issue was not provided.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system # 50506 was reviewed.There are no additional complaints is similar to reported issue.A manufacturing record evaluation was performed for the system #50506, and no internal actions 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).It was discovered the concomitant products were inadvertently omitted from section d10.Concomitant med products of the 3500a initial medwatch report.As such, the products have now been added.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• 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
• MDR Report Key: 15812195
• MDR Text Key: 307914851
• Report Number: 2029046-2022-02847
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: STIMULATOR BY FUKUDA DENSHI CO., LTD; UNKNOWN CS CATHETER