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

Model Number FG540000

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.When using cartosound, fast-anatomical mapping (fam), and cartomerge, it was observed that the map on the carto 3 system had shifted, and the catheter location was no longer where it used to be.There were no error messages or alerts displayed on the carto 3 system, but the map had shifted by about 4cm.The physician was concerned, and the lasso catheter was replaced with a pentaray catheter.They built a new left atrium fam map with the pentaray catheter, but the map was still off by about 4cm.Then it was reported that the carto 3 system displayed error 1104--there is not enough free memory.It was also reported that at this point the ablation catheter and the pentaray catheter were jumping all over the screen.The team rebooted the carto 3 system workstation, continued the same study, and then noticed that the previous cartomerge map appeared normal and accurate, but the new map they had done with the pentaray catheter was still off.They then used the same lasso catheter as before, instead of the pentaray catheter, and the procedure continued using the original map.The map shift was discovered when the ep was ablating and observed the catheters were no longer contacting the fam or ct in the same spots and intracardiac echo (ice) confirmed the change in location.The issue was seen during ablating.The approximate difference in catheter location before and after map shift was 3-4 mm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The workstation issue is not mdr-reportable.The map shift is mdr-reportable.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 27-jul-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.Device evaluation details: the data was requested for investigation, but no data related to the issue was not provided, according to bwi company representative the data is no longer available.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported map shift issue was not determined.Bwi company representative rebooted the workstation and used a default template.This resolved the issue.System is up and ready for use.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.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
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13411416
• MDR Text Key: 290787437
• Report Number: 2029046-2022-00188
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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: CARTOMERGE; CARTOSOUND; LASSO CATHETER; PENTARAY NAV CATHETER; UNSPECIFIED ABLATION CATHETER