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

Model Number FG540000

Device Problems Pacing Problem (1439); Communication or Transmission Problem (2896)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a carto 3 system during which an error 1 occurred, which resulted in the medical team rebooting the patient interface unit (piu) and workstation.Once the medical team entered into the procedure, the coronary sinus (cs) channel for pacing was open, but the ablation pacing was initiated for an unknown reason.The medical team then restarted the piu and workstation, and the issue resolved.No patient consequences were reported.The pacing leads were connected into the carto3 piu primary pacing port.The pacing itself was a planned occurrence, but there was a brief moment of unwanted pacing.Communication issue (patient interface unit -- piu) is not mdr-reportable.Unwanted pacing is mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 8-may-2023, the product investigation was completed.It was reported that a patient underwent a procedure with a carto 3 system during which an error 1 occurred, which resulted in the medical team rebooting the patient interface unit (piu) and workstation.Once the medical team entered into the procedure, the coronary sinus (cs) channel for pacing was open, but the ablation pacing was initiated for an unknown reason.The medical team then restarted the piu and workstation, and the issue resolved.No patient consequences were reported.Device evaluation details: it was confirmed that the issue was resolved by rebooting the piu (patient interface unit).It was also reported that upon piu reboot the pacing was set to map catheter instead of cs (coronary sinus) catheter.The issue is related to sw (software) defect.The defect is being handled per defect management process.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: 16596163
• MDR Text Key: 311829147
• Report Number: 2029046-2023-00612
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2010
• 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: THE BLOOM ¿ FISCHER MEDICAL PACING STIMULATOR; UNSPECIFIED MAPPING CATHETER