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 09/18/2023

Event Type  malfunction  

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 when the octaray catheter was inserted into the patient it was displayed on the carto® 3 system as flipping upside down, however, the caller stated that they confirmed with x-ray that the octaray catheter came out normally in the sheath.They replaced the cable and the issue persisted.They replaced the octaray catheter with an optrell catheter and the procedure continued.There were no visualization issues or noise issues for the optrell catheter.The caller stated that there appeared to be a map shift on the carto® 3 system.The map shift medial from the lesion set.There were no errors displayed on the carto 3 system, no patient movement, and no cardioversion.The patches did not move, there was no shift in fluoro and no shift in respirations.No troubleshooting was performed.

Manufacturer Narrative

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).

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 when the octaray catheter was inserted into the patient it was displayed on the carto® 3 system as flipping upside down, however, the caller stated that they confirmed with x-ray that the octaray catheter came out normally in the sheath.They replaced the cable and the issue persisted.They replaced the octaray catheter with an optrell catheter and the procedure continued.There were no visualization issues or noise issues for the optrell catheter.Device evaluation details: it was confirmed that the issue was resolved after removing the non-carto device.The system is ready for use.An investigation was initiated by the manufacturer to investigate the issue.It was found that the provided data was only the backup data and it is not sufficient for investigation.The history of customer complaints reported during the last year and associated with carto system # (b)(6) was reviewed.No similar additional complaint was found.The manufacturing record evaluation was performed on carto 3 #(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 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: 17909883
• MDR Text Key: 325444394
• Report Number: 2029046-2023-02276
• 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: 10/10/2023

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: 09/18/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OCTA,LNG,48P,3-3-3-3-3,D-CURVE; UNKNOWN RECORDING SYSTEM; UNK_OPTRELL MAPPING CATHETER