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  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and the map shift had no error message, no patient movement and no cardioversion performed.While mapping in the left and right atriums, there was a map shift on the carto® 3 system.Between the last case and this case, the patient interface unit (piu) and workstation were shut down.The procedure continued.There was no patient consequence reported.Additional information was received on 12-mar-2024.There was no error on the system.No cardioversion was performed during the case and no patient movement was noticed.The map shift was discovered when ablation started, the catheter vector did not correspond to the expected vector at the location seeing on the map.A cs snapshot was also used to notice the shift.The approximate difference in catheter location before and after map shift was about the distance between the tip and the proximal electrodes on the smarttouch sf catheter.The event was originally considered non-reportable, however, bwi became aware of additional information stating the map shift had no error message, no patient movement and no cardioversion was performed on 12-mar-2024 and have reassessed the map shift issue as reportable.Therefore, the awareness date for this reportable record is 12-mar-2024.

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 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: 19009046
• MDR Text Key: 339228742
• Report Number: 2029046-2024-01071
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• 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
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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: UNK SMARTTOUCH SF CATHETER