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

Catalog Number FG540000

Device Problem Signal Artifact/Noise (1036)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt) ablation procedure with a carto 3 system and there was noise on ablation catheter (themocool), and ecg (electrocardiogram) signal (on all leads), on both carto and electrophysiology recording system (eprs).The noise was confirmed to occur during ablation only.The medical team replaced the ecg in cable prior to the operation.It was not confirmed if the ecg out and ic out had been replaced.The system has been also checked in october/november 2023 and passed the tests.Everything was fine, ports including.No external or visible damages on any components have been noticed.The physician was not interested in those signals for this case.They removed the ecg cable and plugged it back in but the noise persisted.The physician continued the procedure with the noise, but the medical team believed these signals would be important for future cases.No components have been replaced in this case.The procedure was completed with no procedural delay or patient consequences.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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

On 18-apr-2024, the product investigation was completed.It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt) ablation procedure with a carto 3 system and there was noise on ablation catheter (themocool), and ecg (electrocardiogram) signal (on all leads), on both carto and electrophysiology recording system (eprs).The noise was confirmed to occur during ablation only.The medical team replaced the ecg in cable prior to the operation.It was not confirmed if the ecg out and ic out had been replaced.The system has been also checked in october/november 2023 and passed the tests.Everything was fine, ports including.Device evaluation details: the field service engineer arrived to the customer and performed follow up cases.The issue was not duplicated through all follow up cases.In addition, the manufacturer reviewed the received data and found that the noise was observed on m1 m2 ecg electrodes only.It was not observed on other electrodes.It was concluded that the noise was not caused by carto 3 system but by external source.The carto 3 is operational.The manufacturing record evaluation was performed on 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: 18769724
• MDR Text Key: 337077827
• Report Number: 2029046-2024-00606
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 01/31/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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