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

Catalog Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto 3 system and while the patient was intubated and mapping in the left atrium occurred, there was a map shift on the carto.There was no error on the system.The map shift was discovered when ablation started, and the catheter vector did not correspond to the expected vector at the location seeing on the map.A coronary sinus (cs) snapshot was also used to notice the shift.The issue was seen during ablation.The approximate difference in catheter location before and after map shift was about the distance between the tip and the proximal electrodes on the thermocool smarttouch catheter.No cardioversion was performed during the case and no patient movement was noticed.It is unknown how the issue was resolved.But it was confirmed that the procedure continued.No patient consequences were reported.

Manufacturer Narrative

On 1-may-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto 3 system and while the patient was intubated and mapping in the left atrium occurred, there was a map shift on the carto.There was no error on the system.The map shift was discovered when ablation started, and the catheter vector did not correspond to the expected vector at the location seeing on the map.A coronary sinus (cs) snapshot was also used to notice the shift.The issue was seen during ablation.The approximate difference in catheter location before and after map shift was about the distance between the tip and the proximal electrodes on the thermocool smarttouch catheter.No cardioversion was performed during the case and no patient movement was noticed.It is unknown how the issue was resolved.But it was confirmed that the procedure continued.No patient consequences were reported.Device evaluation details: the manufacturer investigated the issue.It was confirmed that the issue was resolved by reimaging the carto 3 workstation.The system is ready for use.It was found that the reported issue is related to patient movement - user error.According to carto 3 instructions for use, (p.N.Ug-5400-007h, rev.00a ): "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated." the manufacturing record evaluation was performed on carto 3 #34744, 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).

• 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: 19053743
• MDR Text Key: 340452890
• Report Number: 2029046-2024-01143
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: 03/12/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2018
• 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: THERMOCOOL SMARTTOUCH