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 10/02/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia cardiac ablation procedure with a carto® 3 system and immediately after the procedure, a pacing spike entered after 2 seconds from pacing through carto3, and cardiac cavity a wave was captured.The procedure was continued and completed without any problems.No adverse patient consequence was reported.

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 paroxysmal supraventricular tachycardia cardiac ablation procedure with a carto® 3 system and immediately after the procedure, a pacing spike entered after 2 seconds from pacing through carto3, and cardiac cavity a wave was captured.The procedure was continued and completed without any problems.No adverse patient consequence was reported.Hardware evaluation details: pacing was performed at the facility using jumper cables without going through carto 3 system.The customer has informed that the system is operating normally.In addition, an investigation was initiated by the manufacturer to look into the issue further.The data was requested for investigation; however, no data was available for review.As a result, it was not possible to reproduce or analyze the issue.The root cause of the reported issue was not determined.The system is operational.The history of customer complaints reported during the last year associated with carto 3 system # 55575 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed on carto 3 system #55575, 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: 18026191
• MDR Text Key: 327049464
• Report Number: 2029046-2023-02467
• 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: 10/02/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1