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

Catalog Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Computer Operating System Problem (2898)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto® 3 system and a mapshift with no error message, no patient movement and no cardioversion issue occurred.Initially it was reported that it seemed like the patient's respiration was causing a map shift.No errors displayed on the carto 3 system related to respiration.To troubleshoot, they tried to retrain respiration without resolution.They utilized intracardiac echocardiography (ice) to make sure they were in the right location.No patient consequence was reported.Additional information was received on 13-nov-2023.The ablator would fall down on carto mapping screen, but stay in place on ice.The issue was seen during mapping and ablating.The approximate difference in the catheter location before and after the map shift was probably 3 cm difference.No cardioversion and the patient did not appear to move.This event was originally considered non-reportable, however, bwi became aware of that this was a mapshift with no error message, no patient movement and no cardioversion on 13-nov-2023 and have reassessed the event as reportable.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.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

The investigation was completion (b)(6) 2024.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto® 3 system and a mapshift with no error message, no patient movement and no cardioversion issue occurred.An investigation was initiated by the manufacturer to investigate the issue.The data was requested for investigation, but no full data available to investigate this case.There are missing files from the zipped folder, the data is damaged and cannot be recovered.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported issue was not determined.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.A manufacturing record evaluation was performed for the carto 3 system # (b)(4), 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 reference number: (b)(4) during further review on (b)(6) 2024, noted correction to the h6.Medical device problem code field and removed poor quality image ((b)(4)) and computer operating system problem ((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: 18288482
• MDR Text Key: 330823956
• Report Number: 2029046-2023-02878
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2014
• 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