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

Catalog Number FG540000

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed on 17-jul-2023.It was reported that error 7: "leakage current detected on piu rl input" appeared on carto 3 system.Spare catheter was used to resolve the issue.It was confirmed that although the issue was resolved by replacing the catheter, due to reoccurring issues, the biosense webster inc.(bwi) field service engineer (fse) replaced the backplane card and the issue was resolved.The system is ready for use.The suspected backplane card was sent to the device manufacturer for investigation and repair.It was found that the issue was caused due to damaged connectors on the backplane card.The card was repaired, and the issue resolved.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system # 11646, and no internal actions related to the reported complaint condition were identified.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-00723 for product code d134805 (thermocool® smart touch¿ bi-directional navigation catheter).(2) mfr # 2029046-2023-01645 for product code fg540000 (carto 3 system).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.Manufacturer's reference number: (b)(4).

Event Description

This event was assessed as mdr reportable under the thermocool® smart touch¿ bi-directional navigation catheter and reported under mfr # 2029046-2023-00723.Additional information was received on 03-jul-2023 also linking the reportable signal issue to the carto 3 system.Therefore, assessed the reportable signal issue also under the carto 3 system with the awareness date of 03-jul-2023.It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a and a carto® 3 system and loss of all ecg signals issue occurred.Initially, it was reported that an error message regarding leakage current has been detected.They lost signals and connection to carto (no signals on ablation and catheter appeared as ¿not connected¿).The signal interference was observed just on electrocardiogram (ecg) on both carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.The catheter was inside the patient¿s body during the signal loss.The cable was replaced, and the issue was not resolved.When the ablation catheter was replaced, the issue was resolved.There was no patient consequence.Additional information was received on 12-jul-2023.When the cable was replaced, error 105 appeared and they could not see the catheter.Changed catheter and worked.

• 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: 17435722
• MDR Text Key: 320165401
• Report Number: 2029046-2023-01645
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 08/01/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2010
• 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: THMCL SMTCH SF BID, TC, D-F; UNK BRAND CABLE; UNK BRAND CABLE