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

Model Number FG540000

Device Problem Signal Artifact/Noise (1036)

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

Event Date 06/29/2021

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 noise on the ecg signal was observed.Initially, it was reported that during the procedure, noise on the ecg signal was detected.There was no patient consequence.The case was completed and managed to finish with the noise.On (b)(6) 2021, additional information was received and it was reported that the signal noise was on all channels (ic and bs).The signal interference was on all ecg, recording system and carto.The ecg pass by carto first then the ep recording.The physician did not have at least one ecg signal available to monitor the patient heart rhythm.The affected catheter was inside the patient¿s body during the signal interference.The awareness date for this reportable event is (b)(6) 2021.

Manufacturer Narrative

The investigational analysis has been completed on (b)(6) 2021.It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system and noise on the ecg signal was observed.Initially, it was reported that during the procedure, noise on the ecg signal was detected.There was no patient consequence.The case was completed and managed to finish with the noise.On 9-jul-2021, additional information was received and it was reported that the signal noise was on all channels (ic and bs).The signal interference was on all ecg, recording system and carto.The ecg pass by carto first then the ep recording.The physician did not have at least one ecg signal available to monitor the patient heart rhythm.The affected catheter was inside the patient¿s body during the signal interference.The awareness date for this reportable event is 9-jul-2021.The troubleshooting process has been completed and it was found that the defective bs ecg cable is the cause of the issue.The defective bs ecg cable was replaced with a spare one and the issue was resolved.Technical services confirmed that a replacement bs ecg cable was provided to the customer and the issue was resolved.The system is in service and ready for use.It was requested to send the defective bs ecg cable for investigation to the device manufacturer; however, the biosense webster inc.Representative reported that the cable was no longer at the site.It was thrown away by the account.Therefore, the cable was not investigated.The history of customer complaints reported during the last year associated with carto 3 system # 29206 was reviewed.No similar complaints were found.A manufacturing record evaluation (mre) was performed for the carto 3 system # 29206, 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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12277344
• MDR Text Key: 265634871
• Report Number: 2029046-2021-01273
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1