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

Catalog Number FG540000K

Device Problem Pacing Problem (1439)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and during pacing, spike wave occurred two seconds after the original pacing spike, and the myocardium was captured.The pacing leads were connected to the primary pacing port.It was a planned pacing.Since the problem was not resolved, the ¿lab port was closed immediately after the end of the pacing¿.The procedure was completed without any problem.The procedure was completed without patient consequence.

Manufacturer Narrative

E 1.Initial reporter phone: (b)(6).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 a cardiac ablation procedure with a carto® 3 system and during pacing, spike wave occurred two seconds after the original pacing spike, and the myocardium was captured.The pacing leads were connected to the primary pacing port.It was a planned pacing.Since the problem was not resolved, the ¿lab port was closed immediately after the end of the pacing¿.The procedure was completed without any problem.The procedure was completed without patient consequence.Hardware evaluation details: the biosense webster inc.(bwi) field service engineer (fse) visited the account and performed electrocardiogram (ecg) tests per adenosine triphosphate (atp).All tests passed.The fse confirmed that the carto system is in service and ready for use.In addition, an investigation was initiated by the manufacturer to investigate the issue.It was found that the reported issue is related to non-carto device.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system # (b)(6) was reviewed.No similar complaints were found.A manufacturing record evaluation was performed on carto 3 system #(b)(6), 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.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.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: 17831355
• MDR Text Key: 324444277
• Report Number: 2029046-2023-02180
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Catalogue Number: FG540000K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 02/04/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FUKUDA DENSHI BC-2100 PACING STIMULATOR