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

Catalog Number FG540000J

Device Problem Pacing Problem (1439)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

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.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).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a pacing issue (unwanted) occurred.One hour after the start of the procedure, when the pacing was performed from the coronary sinus catheter connected to the ref port of the patient interface unit (piu), a spike-like potential due to discharge was generated 2 seconds after the original pacing spike, and the myocardium was captured.Because the problem could not be resolved, the procedure was continued and completed.The procedure was successfully completed without patient consequence.The pacing lead was connected to the primary pacing port and the carto system did not allow pacing and ablating at the same time.This was a planned pacing; however, there was unwanted pacing being delivered.

Manufacturer Narrative

The hardware investigation was completed on 03-apr-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a pacing issue (unwanted) occurred.One hour after the start of the procedure, when the pacing was performed from the coronary sinus catheter connected to the ref port of the patient interface unit (piu), a spike-like potential due to discharge was generated 2 seconds after the original pacing spike, and the myocardium was captured.Because the problem could not be resolved, the procedure was continued and completed.The procedure was successfully completed without patient consequence.The pacing lead was connected to the primary pacing port and the carto system did not allow pacing and ablating at the same time.This was a planned pacing; however, there was unwanted pacing being delivered.Hardware evaluation details: the data related to the reported issue was provided to the device manufacturer for investigation.The artifact, suspected by the customer as pacing event, always occur after the 2 second mark, after pacing ends.When pacing starts, the ecg filtering is changed to enable the physician to get some insight of the post pacing interval (ppi).When the modified filtering ends, 2 seconds after the last pacing event, the filtering settings are restored to their default.Then the artifact is seen.Conclusion: the phenomena occurred due to a change of filtering after 2 seconds, as the system was designed to do.An internal investigation was conducted, and the defect was closed as a system limitation.In addition, the system frs was updated with the following note: ¿after the stimulation ends there is an additional pulse about 2 seconds after the last stimulation event.This pulse is an artifact on the signal.It is a system limitation.The post-stimulation spike is only an internal electrical artifact that does not deliver any energy via the stimulation port.The system is ready for use.¿ the history of customer complaints reported during the last year associated with carto 3 system # 50549 was reviewed.No similar complaints were found.A manufacturing record evaluation (mre) was performed for the system # 50549, and no internal actions related to the reported complaint condition were identified.Based on the mre, the h 4.Device manufacture date has been updated.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 (FOR JAPAN)
• 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 ; IS
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12171461
• MDR Text Key: 261731162
• Report Number: 2029046-2021-01130
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2012
• 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: NIHON KOHDEN CORP UNKNOWN PACING STIMULATOR.; UNKNOWN CORONARY SINUS CATHETER.; NIHON KOHDEN CORP UNKNOWN PACING STIMULATOR; UNKNOWN CORONARY SINUS CATHETER