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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Application Program Problem (2880)

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

Event Date 07/12/2021

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift with no error message, patient movement or cardioversion issue occurred.The pentaray catheter would not build matrix.The cable was replaced (not the 20 pole eco adapter) and the issue did not resolve.The catheter was replaced and the splines of the pentaray catheter would flicker in and out.The reporter seemed to think this was a bad custom template or a corrupt study.They exited the study then re-entered the same study stating that the new map was anatomically different than the original without patient movement.No further troubleshooting was completed.The case was completed at the time of the call.The system did not provide an error.Original map and final map were visually different.Lesions sets did not match original anatomy.The issue was seen during mapping and ablating for most of the case.The approximate difference in catheter location before and after map shift: original roof line was internal.Force requirements were set but the visit where obviously internal on the final map.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The ¿catheter visualization¿ issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The ¿unable to map¿ issue was assessed as not mdr reportable.Since the catheter cannot map by the carto 3 system, the user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The ¿map shift with no error message, patient movement or cardioversion¿ was assessed as a mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift with no error message, patient movement or cardioversion issue occurred.The system did not provide an error.Original map and final map were visually different.Lesions sets did not match original anatomy.The issue was seen during mapping and ablating for most of the case.The approximate difference in catheter location before and after map shift: original roof line was internal.Force requirements were set but the visit where obviously internal on the final map.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.Device evaluation details: the device manufacturer requested full case data to investigate the reported product issue.However, only partial data was provided as according to the biosense webster inc.Representative, that was all information available on the carto 3 system.With the provided information, an investigation of the map shift issue was not possible.It was reported that the next case completed successfully.The map shift issue was not duplicated and the system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system with serial # (b)(6) was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system with serial # (b)(6), 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
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12278244
• MDR Text Key: 265824025
• Report Number: 2029046-2021-01277
• 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: 07/12/2021

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
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNK_PENTARAY