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

Catalog Number FG540000J

Device Problem Pacing Problem (1439)

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

Event Date 01/01/2023

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.E1.Initial reporter phone: (b)(6).Note: the date of event was not provided.As such, field b3.Date of event has been populated with (b)(6) 2023.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 a cardiac ablation procedure with a carto® 3 system and unwanted pacing occurred.It was reported that unwanted pacing was delivered.Described as short extra stim (between 60 & 190 ms) that isn't programmed occurring at the end of some pacing trains.This was a planned pacing procedure.The pacing leads were connected to the primary pacing port, pacing from map 1-2 while ablating wasn¿t attempted.There was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and unwanted pacing occurred.It was reported that unwanted pacing was delivered.Described as short extra stim (between 60 & 190 ms) that isn't programmed occurring at the end of some pacing trains.This was a planned pacing procedure.The pacing leads were connected to the primary pacing port, pacing from map 1-2 while ablating wasn't attempted.There was no patient consequence.Device evaluation details: an investigation was initiated by the manufacturer to investigate the issue.It was found that according to the provided that there were no spike events.Carto does not include pacing unit, and no extra stimulation is seen at the time mentioned.The history of customer complaints reported during the last year and associated with carto 3 system # 50119 was reviewed.0 similar additional complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 50119 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).

• 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: 17985036
• MDR Text Key: 326264730
• Report Number: 2029046-2023-02397
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042999
• 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

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: FG540000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MICROPACE STIMULATOR