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

Model Number FG540000

Device Problems Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

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

Event Date 02/11/2021

Event Type  Injury  

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.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 that a patient underwent an atrioventricular reentrant tachycardia avrt/wolff-parkinson-white (wpw)ablation.An error 1: no communication with the patient interface unit (piu) detected, was present on the carto 3 system 20 minutes into the procedure.This resulted in the cancellation of the case after the patient was under anesthesia for approximately 2 hours.The error 1: no communication with the piu detected, was present on the carto 3 system 20 minutes into the procedure.To troubleshoot the piu and workstation were rebooted, the fiber optic cable was reseated while the system was off, without resolution.The fiber optic cable was exchanged, and system rebooted again, and it was operational for 20 more minutes then the error 1 appeared again.The original fiber optic cable was then connected again, and system rebooted, error 1 persisted.During the reboot of the piu they waited 3 minutes before booting the workstation back up.The team was advised to reconnect within 15 seconds of the piu and starting a new study.The system then initialized fully without the error.Then they were advised to use the second (ethernet port 1 on the right) on the piu and rebooting.This was done, the initial study continued.The same issue recurred, and the case was aborted as a result.Since the event is life-threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11408872
• MDR Text Key: 245007900
• Report Number: 2029046-2021-00276
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention