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

Model Number FG540000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Device code "no code available" is being used to represent the reportable procedure cancellation.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 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: pc (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a carto 3 system where procedure cancellation occurred.Communication was lost between the workstation and the patient interface unit on the carto 3 system.This occurred towards the end of the procedure.An error code 1 occurred.The fiberoptic cable was changed but the issue persisted.A full system reboot was performed: as a result, the system prompted for the system activation password but the unique was different.It was determined by the on-call field service engineer that the workstation required replacement.The patient was under general anesthesia.From 07:30 until the system crashed.A transseptal was performed before the system crashed.The procedure cancellation is mdr reportable.The carto communication and workstation issues in and of themselves are not reportable.

Manufacturer Narrative

On 11/10/2020, the product investigation was completed.It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a carto 3 system where procedure cancellation occurred.Communication was lost between the workstation and the patient interface unit on the carto 3 system.This occurred towards the end of the procedure.An error code 1 occurred.The fiberoptic cable was changed but the issue persisted.A full system reboot was performed: as a result, the system prompted for the system activation password but the unique was different.It was determined by the on-call field service engineer that the workstation required replacement.The patient was under general anesthesia.From 07:30 until the system crashed.A transseptal was performed before the system crashed.Device evaluation details: the field service engineer replaced workstation with a new one.All licenses were activated, and patches were displayed accurately.The field service engineer provided case support.No issues observed after workstation replacement.System is ready for use.Replaced workstation was sent to the device manufacturer for investigation (investigation request # (b)(4) ).It was found that the fiber optic communication card (nic) was slightly loose in its slot.Once fastened to its slot (there was a "click") and turned on the workstation the issue resolved, and system showed original unique id.The workstation was investigated by the device manufacturer subcontractor (bynet).No failure with communication card was found.The workstation was reimaged and tested.The workstation is operational.A manufacturing record evaluation was performed for the system (b)(4) and workstation (b)(4), 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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10571173
• MDR Text Key: 208133006
• Report Number: 2029046-2020-01308
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1