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

Model Number FG540000

Device Problems Computer Operating System Problem (2898); Patient Device Interaction Problem (4001)

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

Event Date 12/30/2022

Event Type  Injury  

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).

Event Description

It was reported a patient undergoing a ventricular tachycardia procedure with a carto 3 system.The system crashed and the procedure was cancelled.It's been reported an issue with the carto system.It's been said the system crash in the middle of the procedure.They tried to reboot several time but keep getting stuck on the default template screen.It's been said they keep getting the message "the carto system will shutdown because it crashed." case cancelled.The patient had been under general anesthesia for 5 hours.No transseptal puncture performed prior to the case cancellation.No reported patient consequences.In the physician¿s opinion, carto system failure was part of the decision to stop ongoing treatments.But it was not the only one, it was already late in the day, patient had multiple incessant vt over a laminopathy, a rare genetic disease.It was probable he would also suffer severe brain injury from a previous heart failure.It was proposed to switch the systems between the two operating theaters in (b)(6), physician declined.Time estimated to switch systems : 20/30 minutes.The software crash is not mdr-reportable.However, the reported event in this specific situation has been determined to be life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On 24-apr-2023, the product investigation was completed.It was reported a patient undergoing a ventricular tachycardia procedure with a carto 3 system.The system crashed and the procedure was cancelled.It's been reported an issue with the carto system.It's been said the system crash in the middle of the procedure.They tried to reboot several time but keep getting stuck on the default template screen.It's been said they keep getting the message "the carto system will shutdown because it crashed".Case cancelled.The patient had been under general anesthesia for 5 hours.No transseptal puncture performed prior to the case cancellation.No reported patient consequences.Device evaluation details: field service engineer (fse) confirmed that workstation (ws) successfully re-imaged according to manual.Issue solved.After the issue was reproduced, the faulty ws was replaced with another one that was delivered to the customer.The issue was resolved.The system is ready for use.A manufacturing record evaluation was performed for the system #10320, and no internal actions related to the reported complaint condition were identified.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.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: 16241307
• MDR Text Key: 308178286
• Report Number: 2029046-2023-00154
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• 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
• Patient Outcome(s): Life Threatening