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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Connection Problem (2900); Electrical Shorting (2926); Patient Device Interaction Problem (4001)

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

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system.A current leakage error issue occurred causing a case delay.It was reported that they had an error "leakage current" with the pin box.They also lost all signal on ecg, on both carto and eprs (recording system).They tried to disconnect and reconnect everything, but they had the same issues.They had to completely disconnect the pin box to get the ecg signals again.They didn't have any spare pin box available, so they did not solve the leakage current issue.They did not use cs catheter and complete the procedure.There were no patient consequences.A thirty (30) minute delay was reported.(carto system versionv.7.1.80.33.) additional information was received on 18-oct-2022.In the physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.No intervention was required due to the delay (such as defibrillation, cpr, chest compressions, medication).Follow up has been requested to clarify if there was external ecg available a response was received on (b)(6) 2022 stating that this information is unknown.The pin box and current leakage issues were assessed as not mdr reportable.These issues are highly detectable.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote the surgery prolonged issue was assessed as mdr reportable.

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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The hardware investigation was completed on 11-dec-2022.It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system.A current leakage error issue occurred causing a case delay.It was reported that they had an error "leakage current" with the pin box.They also lost all signal on ecg, on both carto and eprs (recording system).They tried to disconnect and reconnect everything, but they had the same issues.They had to completely disconnect the pin box to get the ecg signals again.They didn't have any spare pin box available, so they did not solve the leakage current issue.They did not use cs catheter and complete the procedure.There were no patient consequences.A thirty (30) minute delay was reported.(carto system versionv.7.1.80.33).Hardware investigation details: it was confirmed that replacement pin box was delivered to the customer.The suspected pin box was requested for investigation by the manufacturer, however, the biosense webster representative confirmed that the cable has been disposed of by the hospital staff.The system is ready for use.A history of customer complaints reported during the last year associated with carto 3 system # (b)(6) was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the 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: 15734378
• MDR Text Key: 303071490
• Report Number: 2029046-2022-02731
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other