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 04/08/2024

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 occurred.It was reported that after building the initial voltage map, it was noticed that there was a map shift on the carto 3 system.The caller reported that there were no errors or alerts displayed on the carto 3 system.The procedure continued and completed.The caller reported that after the procedure, when performing a re-map, it was confirmed that the map had shifted by about 10mm.There was no patient consequence.On 12-apr-2024, additional information was received indicating there were no errors.High contact on ablation catheter and the visitag was visibly deep from the fast anatomical map (fam) shell surface.The physician did not perform cardioversion prior to the map shift and if the patient did move it was not enough to be recognized by system.Based on this new information, the event was reassessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred.It was reported that after building the initial voltage map, it was noticed that there was a map shift on the carto 3 system.The caller reported that there were no errors or alerts displayed on the carto 3 system.The procedure continued and completed.The caller reported that after the procedure, when performing a re-map, it was confirmed that the map had shifted by about 10mm.There was no patient consequence.Device evaluation details: an investigation was initiated by the manufacturer to investigate the issue.The data was requested for an investigation, but no full data was available to investigate this case, only backup.As a result, it was not possible to reproduce or analyze the issue.The root cause of the reported issue was not determined.The history of customer complaints reported during the last year and associated with carto 3 system # 29173 was reviewed.No similar additional complaints were found.A manufacturing record evaluation was performed for the carto 3 system 29173, 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.# (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: 19214485
• MDR Text Key: 341437325
• Report Number: 2029046-2024-01400
• 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

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
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1