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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926)

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

Event Date 08/23/2021

Event Type  malfunction  

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 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 that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system and no ecg was visible for the physician to monitor the patient¿s heart rhythm.Initially it was reported that during the procedure, there was an error 7 leakage current and an error 8 routine stimulation issue.Rebooted the patient interface unit (piu) and replaced the catheter and the cable.There was no patient consequence.The current leakage error 7 was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The error 8 routine stimulation issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on the event on (b)(6) 2021.The current leakage error was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) observed on all ecg (bs + ic).The signal interference (noise/loss) was observed on both the carto 3 system and the recording system.It was also observed on the anesthesia monitor.There was no ecg visible for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.The issue of ¿no ecg was visible for the physician to monitor the patient¿s heart rhythm¿ was assessed as a mdr reportable malfunction.The awareness date for this reportable issue is (b)(6) 2021.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system.Initially it was reported that during the procedure, there was an error 7 leakage current and an error 8 routine stimulation issue.Rebooted the patient interface unit (piu) and replaced the catheter and the cable.There was no patient consequence.Additional information was received on the event on (b)(6)2021.The current leakage error was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) observed on all ecg (bs + ic).The signal interference (noise/loss) was observed on both the carto 3 system and the recording system.It was also observed on the anesthesia monitor.There was no ecg visible for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.The investigation was completed on (b)(6)2021: it was reported that an error 7 and error 8 appeared spontaneously in middle of ablation.The issues were solved after changing ablation catheter.It was a recurrent issue in the hospital.When on site, the biosense webster, inc.Field service representative confirmed a physically damaged map port and other ports located on the patient interface unit (piu) backplane card.The biosense webster, inc.Field service representative replaced the damaged backplane card with a new one.A preventative maintenance / acceptance testing procedure tests were performed after backplane card replacement.All tests passed.Issues are resolved.The system is in service and ready for use.It was requested to send the damaged backplane card for investigation to the device manufacturer.However, the backplane card device manufacturer rma investigation cannot be performed due to damaged backplane card was scrapped in the emea quest warehouse.The history of customer complaints reported during the last year associated with carto 3 system #11195 was reviewed.A manufacturing record evaluation was performed for the carto 3 system # 11195, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate the damaged connectors on backplane cards issue.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
• MDR Report Key: 12475450
• MDR Text Key: 271507237
• Report Number: 2029046-2021-01554
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2010
• 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: UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM