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 09/29/2023

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).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 paroxysmal supraventricular tachycardia ablation procedure with a carto® 3 system and a pacing spike through carto® 3 system was captured cardiac cavity a wave.It was reported that about 1 hour after the patient entered the room, the physician complained that after 2 seconds, the issue that pacing spike captured cardiac cavity occurred with reproducibility.The bwi representative explained that pacing spike after 2 second was not transmitted cardiac cavity.The physician complained that bard was automatically logged by pacing spike.In response, it was explained that spike would not enter the lab by transmitting it to the lab pin box with the jumper not through carto® 3 system, but the physician complained that there was no jumper anymore.The procedure was continued with spike in it and the procedure itself was completed without any problems.They were pacing from the primary pacing port with a nihon kohden pacing stimulator.This was a planned pacing procedure.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a carto® 3 system and a pacing spike through carto® 3 system was captured cardiac cavity a wave.It was reported that about 1 hour after the patient entered the room, the physician complained that after 2 seconds, the issue that pacing spike captured cardiac cavity occurred with reproducibility.The bwi representative explained that pacing spike after 2 second was not transmitted cardiac cavity.The physician complained that bard was automatically logged by pacing spike.In response, it was explained that spike would not enter the lab by transmitting it to the lab pin box with the jumper not through carto® 3 system, but the physician complained that there was no jumper anymore.The procedure was continued with spike in it and the procedure itself was completed without any problems.Device investigation details: it was confirmed that no catheter stimulation occurred during pacing and preventing action will be made for future cases.The system is ready for use.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 manufacturing record evaluation was performed on carto 3 # 55575, and no internal actions related to the reported complaint condition were identified.The history of customer complaints reported during the last year and associated with carto system # 55575 was reviewed.No similar additional complaint was found.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: 18011236
• MDR Text Key: 326613989
• Report Number: 2029046-2023-02434
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 09/29/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• 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 STIMULATOR