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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

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 an atrial fibrillation (afib) cardiac ablation procedure with a carto 3 system where a map shift with no error message, no patient movement and no cardioversion issue occurred.Initially, it was reported that during the procedure, when going to the left side of the heart to begin ablation, after creating fast anatomical mapping (fam) for the left atrium, it was noticed that the visitags were not lining up with the fam.The visitags were completely outside of the fam zone.No error messages or alerts were displayed on the carto 3 system, and no fluoroscopy system was in use.At the same time, when heading towards the right side of the heart, the pentaray catheter splines had disappeared, and reappeared shortly after.A new map was created, and the issue had resolved.The procedure continued.There was no report of patient consequence.Multiple attempts had been made to obtain clarification to this complaint.With the information available, the event was assessed as a visitag issue and a map shift issue.The visitag issue was assessed as not mdr reportable.The visitag provides supplemental information to aid in ablation procedures.If visitags points are lost, inaccurate, or unable to be obtained, then this would be highly detectable.The acquisition of visitag points is not necessary to perform ablation procedures.Points can be taken manually, and ecg rhythm is the ultimate guiding feature of ablation procedures.An issue with visitags does not affect patient risk.The map shift issue reported does not indicate that there was no patient movement and no cardioversion performed.Therefore, this map shift event was assessed as not mdr reportable.Additional information was received on 10/16/2020.There was no problem with visitags.No information was lost.No inadvertent ablation was performed.System did not provide any error.Map shift was discovered when visitags were well outside the fast anatomical mapping shell.Issue was seen during the ablation.The difference was approximately 8mm.No cardioversion was performed and patient never moved.To complete the procedure, the left atrium was remapped with the pentaray catheter and continued with pulmonary vein isolation (pvi).Per the additional information received stating that this was a map shift issue with no error message, no patient movement and no cardioversion, this complaint was reassessed to a mdr reportable malfunction and the awareness date is 10/16/2020.The catheter visualization 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.

Manufacturer Narrative

The device evaluation was completed on 12/7/2020.It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a carto® 3 system.It was reported that during the procedure, when going to the left side of the heart to begin ablation, after creating fam for the left atrium, the caller had noticed that the visitags were not lining up with the fast anatomical mapping.It was reported that the visitags were completely outside of the fam zone.There were no error messages or alerts which displayed on the carto 3 system and no fluoroscopy system was in use.The caller noted that at the same time, when heading towards right side of the heart, the pentaray catheter splines had disappeared and reappeared shortly after.System did not provide any error.Map shift was discovered when visitags were well outside the fam shell.Issue was seen during ablation.The difference was approximately 8mm.No cardioversion was performed, and patient never moved.To complete the procedure the left atrium was remapped with the pentaray catheter and continued with pulmonary vein isolation (pvi).For the reported pentaray visualization issue, the biosense webster field service representative confirmed that the issue was resolved with a reboot and creation of a new map.For the map shift issue, it was reported that a new map (remap) was created, and the issue had resolved.The procedure continued.There was no problem with visitags.No information was lost.No inadvertent ablation was performed.There was no report of patient consequence.Data related to the reported issue was sent to the the device manufacturer for investigation.The issue was investigated by the device manufacturer.The issue could not be reproduced by the device manufacturer.No additional investigation can be performed as the data related to the issue arrived without recordings.In addition, the biosense webster representative provided a photo of the map shift.The photo was reviewed and it confirmed information provided in the event description.However, it lacked information and based on the provided information, the investigation of the map shift issue was not possible.The biosense webster field service representative confirmed that the issue was not reproduced since then.The system is operational.A manufacturing record evaluation was performed for the carto 3 system #: (b)(6), and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate map shifts.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10840448
• MDR Text Key: 216413099
• Report Number: 2029046-2020-01722
• 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: 10/07/2020

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: 10/16/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK PENTARAY.