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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Material Integrity Problem (2978)

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

Event Date 07/02/2021

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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.There was a map shift with no errors on the carto 3 system.The caller stated that the patient didn't move.The caller also stated they had started ablation on the left-sided vein when they felt like the fast anatomical mapping (fam) was incorrect.They moved the catheter to the right-sided veins and the intracardiac echocardiography (ice) image was not matching the fam image.The caller stated the fam displayed the catheter on the posterior wall.The caller stated that the respiratory graph went flat and the tidal volume was reduced.They re-mapped and the issue was resolved.Map shift did not duplicate, upon speaking with the biosense webster inc.(bwi) representative reported it appears the location pad holder was bent and needed to be replaced.Additional information received confirmed the issue was seen during ablating and no error message was given.Error was noticed using ice in la at the right superior pulmonary vein (rspv) and ablation tip.In ice ablation was at rspv but in fam map it was in the center of posterior wall.The approximate difference in catheter location before and after map shift: approximately 4cm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.

Manufacturer Narrative

There was a map shift with no errors on the carto 3 system.The caller stated that the patient didn't move.The caller also stated they had started ablation on the left-sided vein when they felt like the fast anatomical mapping (fam) was incorrect.They moved the catheter to the right-sided veins and the intracardiac echocardiography (ice) image was not matching the fam image.The caller stated the fam displayed the catheter on the posterior wall.The caller stated that the respiratory graph went flat and the tidal volume was reduced.They re-mapped and the issue was resolved.Device evaluation details: the issue has been investigated.It was found that the reported map shift was caused due to high metal values during fast anatomical mapping (fam) acquisition.The issue is related to a known software defect.An internal corrective action has been opened to investigate map shifts.It was also reported that the location pad holder was found physically damaged.It was confirmed that replacement green patch sensors cable was delivered to the customer and the system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #10125 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 10125, and no internal action 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 ref.# (b)(4).

Manufacturer Narrative

On 17-oct-2021, the manufacturing date of the unit was provided as 15-jun-2010.As such, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• MDR Report Key: 12229725
• MDR Text Key: 263604836
• Report Number: 2029046-2021-01197
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 09/01/2021; 10/17/2021
• Supplement Dates FDA Received: 09/24/2021; 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1