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)

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

Event Date 08/28/2023

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.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 an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the caller, the bwi representative, that while creating the matrix with the octaray catheter, they started on ablation, continued to map while in the left atrium, and once they started to burn the left pulmonary vein on the ridge, they noticed a significant map shift.The caller reported that the map looked like it shifted up by approximately 20mm.The caller reported that electrode 2 was sometimes black, but they could create matrix.To troubleshoot the caller checked the metal values and made sure the spu was far enough away from everything without resolution.The caller created a new map, they experienced no further shifts, and the procedure was continued.On (b)(6) 2023, additional information received indicated there were no errors provided by the system.They observed that the octaray catheter was outside of the initial map created.The issue was seen during ablation.No cardioversion or patient movement.The patient was on ¿jet¿ the entire case.This event was originally considered nonreportable, however, bwi became aware of additional information on (b)(6) 2023 and have reassessed the event as an mdr reportable malfunction for the map shift.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the caller, the bwi representative, that while creating the matrix with the octaray catheter, they started on ablation, continued to map while in the left atrium, and once they started to burn the left pulmonary vein on the ridge, they noticed a significant map shift.The caller reported that the map looked like it shifted up by approximately 20mm.The caller reported that electrode 2 was sometimes black, but they could create matrix.To troubleshoot the caller checked the metal values and made sure the spu was far enough away from everything without resolution.The caller created a new map, they experienced no further shifts, and the procedure was continued.On 31-aug-2023, additional information received indicated there were no errors provided by the system.They observed that the octaray catheter was outside of the initial map created.The issue was seen during ablation.No cardioversion or patient movement.The patient was on ¿jet¿ the entire case.Device evaluation details: it was confirmed that the issue was not duplicated in the following case.The system is ready for use.An investigation was initiated by the manufacturer to investigate the issue.The provided data was insufficient to conduct investigation, no more data was available.The manufacturing record evaluation was performed on carto 3 #14692, 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 ref.# pc-(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: 17821665
• MDR Text Key: 324334333
• Report Number: 2029046-2023-02167
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2014
• 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
• Treatment: UNK_OCTARAY NAV.