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

Model Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial tachycardia (at) cardiac ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the biosense webster inc.(bwi) representative that during an atrial fibrillation, a map shift occurred during atrial tachycardia case.The patches were checked to ensure that the patient did not move, ¿redo another map to manage to ablate and complete the procedure¿.There was a five-to-ten-minute delay due to this event.There were no patient consequences.The map shift issue is mdr reportable to the us fda.

Manufacturer Narrative

E 1.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.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 hardware evaluation was completed on 20-jun-2023.It was reported that a patient underwent an atrial tachycardia (at) cardiac ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the biosense webster inc.(bwi) representative that during an atrial fibrillation, a map shift occurred during atrial tachycardia case.The patches were checked to ensure that the patient did not move, ¿redo another map to manage to ablate and complete the procedure¿.There was a five-to-ten-minute delay due to this event.There were no patient consequences.Hardware evaluation details: the bwi field service engineer (fse) followed up and confirmed that the system was fully functional, also from the magnetic point of view.The study data, which was related to the reported issue, was exported from the system and it was sent to the device manufacturer for investigation.It was confirmed that the map shift was caused by the user that worked with high and low metal levels that created non-consistent anatomy.Errors were visible but most probably have been ignored.In addition, patient movement was observed.The reported map shift was related to user error.The system was ready for use.The history of customer complaints reported during the last year and associated with carto 3 system (b)(6) was reviewed and one additional complaint similar to the reported issue was found.A manufacturing record evaluation was performed for the carto 3 system (b)(6), 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: 16818177
• MDR Text Key: 314043974
• Report Number: 2029046-2023-00900
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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: UNK_OCTARAY NAV