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

Catalog Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Electrical Shorting (2926)

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

Event Date 08/23/2023

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift with no error message, no patient movement and no cardioversion issue occurred.The carto® 3 system displayed a current leakage error when coming on for electrocautery.They disconnected all catheters and cables from the patient interface unit (piu).They reconnected the catheters and cables one by one and the issue was resolved.They then reported that after the 2nd transseptal procedure, the same issue occurred with a current leakage error.They performed the same troubleshooting by disconnected all catheters and cables one by one and reconnecting.The issue would resolve.They reported that ever since the new signal processing unit (spu) install, they have been getting current leakage errors more often.They noted that no indifferent electrodes were connected to the generator at the time of electrocautery delivery during transseptal.They then reported that when creating the map for the left side, and when the physician had started ablating, it was noticed that there was a small map shift in the right veins.They noted that the intracardiac echocardiography (ice) catheter was in the body at the time, but no other catheters were in the body.They reported that it was then noticed that a much larger shift was present in the left veins.They reported that the map shift on the left side appeared to be about 2.5cm.They noted that no error messages were displayed and there was no patient movement.The physician canceled the procedure and the patient was cardioverted.There was no patient consequence reported.Additional information was received on 24-aug-2023.There was no loss of signal that they could tell.Case appeared to be normal aside from the current leakage error that popped up on the screen.Patient was in the room during cancellation.The patient was under general anesthesia for about 1 hour.Two transseptal punctures we¿re performed prior to cancellation.In the physician¿s opinion, the cancelation of the procedure did not contribute to a death or a serious injury to the patient.It was possible that the patient required extended hospitalization due to a medical condition caused by the procedure cancellation, as they were not able to complete the pulmonary vein isolation (pvi) ablation to terminate the atrial fibrillation.Patient had to be cardioverted.There was no error aside from the current leakage error (does not recall error number).Issue was discovered when they remapped due to 3d anatomy looking incorrect.New 3d showed veins were no longer where they were in the original map were they were made prior to ablation.The map shift issue was seen during ablation.Map shift was approximately 2.5 cm in the left superior pulmonary vein (lspv) and less around the right veins, possibly 0.5-1cm in the right superior pulmonary vein (rspv).There was no patient movement or cardioversion noticed prior to the map shift.The current leakage error was assessed as non mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The map shift with no error message, no patient movement and no cardioversion issue was assessed as mdr reportable.

Manufacturer Narrative

The investigation was completed on 19-oct-2023.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.The carto® 3 system displayed a current leakage error when coming on for electrocautery.It was confirmed that the reported issue was not duplicated since then.The system is ready for use.The complaint history of the system was reviewed, and no more similar problems were found since the issue occurred.They then reported that when creating the map for the left side, and when the physician had started ablating, it was noticed that there was a small map shift in the right veins.They noted that the intracardiac echocardiography (ice) catheter was in the body at the time, but no other catheters were in the body.They reported that it was then noticed that a much larger shift was present in the left veins.They reported that the map shift on the left side appeared to be about 2.5cm.They noted that no error messages were displayed and there was no patient movement.The physician canceled the procedure and the patient was cardioverted.There was no patient consequence reported.An investigation was initiated by the device manufacturer to investigate the issue.It was found that the reported map shift was a result of patient movement during the procedure.The system is ready for use.The complaint history of the system was reviewed, and no more similar problems were found since the issue occurred.The manufacturing record evaluation was performed on carto 3 system #11783, 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: 17760964
• MDR Text Key: 323588110
• Report Number: 2029046-2023-02095
• 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: 11/08/2023

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: 08/23/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2011
• 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 CABLE; UNK GENERATOR; UNK ICE CATHETER