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

Model Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/02/2021

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 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 ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system wherein a map shift issue occurred.Without cardioversion or patient movement.It was reported that a map shift occurred toward the end of the procedure, without any error indicating a shift.The ablation cable was exchanged, without resolution.The physician did not want to troubleshoot further as it was toward the end of the procedure when the shift was noticed.It was also noticed that the reference patch cables were "looped next to the location pad." it is believed that this, along with the patient's large size caused the map shift.Additional information received indicated the map shift was suspected during initial ablation but confirmed at the end as the ablation catheter was definitely outside fast anatomical mapping (fam).The issue seemed to get worse as they ablated.The approximate difference in catheter location before and after map shift was 8mm -10mm.No cardioversion.Patient was under general anesthesia the entire procedure with good control.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system wherein a map shift issue occurred.Without cardioversion or patient movement.Device investigation details: the issue has been investigated.It was found that the map shift was caused by changing metal level, probably by moving the fluoro and a move of the upper body of the patient during the mapping.Issue is related to user error.No follow-up was requested.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #13110 was reviewed.There are no complaints that may be related to the reported issue.A manufacturing record evaluation was performed for the system 13110, 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 ref # (b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• MDR Report Key: 12370307
• MDR Text Key: 268241403
• Report Number: 2029046-2021-01394
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• 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: SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F