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

Catalog Number FG540000K

Device Problems Pacing Problem (1439); Communication or Transmission Problem (2896)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified ablation procedure with a carto 3 system and after a planned pacing in cs9-10, a pacing spike and captured myocardium occurred after m2000msec.The issue occurred when performing cavotricuspid ishmus (cti).The pacing leads were connected to the left-most stimulator port of patient interface unit (piu).The medical team identified that the pacing cable connector was damaged.The procedure was not affected, so it was continued.The procedure was completed without any problems.No patient consequences were reported.The connector is scheduled to be replaced before the next procedure.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The hardware investigation has begun but it has not been completed at this time.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 (b)(6) 2024, the product investigation was completed.It was reported that a patient underwent an unspecified ablation procedure with a carto 3 system and after a planned pacing in cs9-10, a pacing spike and captured myocardium occurred after m2000msec.The issue occurred when performing cavotricuspid ishmus (cti).The pacing leads were connected to the left-most stimulator port of patient interface unit (piu).The medical team identified that the pacing cable connector was damaged.The procedure was not affected, so it was continued.The procedure was completed without any problems.No patient consequences were reported.The connector is scheduled to be replaced before the next procedure.Device evaluation details: the data was requested for investigation, but no full data available to investigate this case.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported issue was not determined.The history of customer complaints reported during the last year and associated with carto 3 system # 55820 was reviewed.0 similar additional complaints were found.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: JPN 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: 17954107
• MDR Text Key: 327037067
• Report Number: 2029046-2023-02345
• 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: 02/21/2024

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: 09/22/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BC-2100, FUKUDA DENSHI (PACING STIMULATOR)