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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Computer Operating System Problem (2898)

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

Event Date 04/29/2022

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.There was an unexplained map shift during the procedure.It was noticed when they were trying to ablate around the left pulmonary vein.They noticed the map didn't line up and that the map had shifted inferiorly.The map shift was confirmed using ultrasound and re famed to continue on with the procedure.Before the map shift occurred, they were unable to use the middle button on the mouse to turn the map as usual.This was temporary and the mouse started working about 2 minutes later.At the end of the procedure, some of the buttons (number keys) on the keyboard also stopped working temporarily for a few minutes before they began to work again.A default template was in use.There was no error reported on the system.When the catheter appeared to be on the inferior side of the lipv, the vector on the smarttouch catheter did not look correct.At that time, the pentaray catheter was moved from the right pulmonary veins to the left pulmonary veins to confirm their location and the position of the veins was shifted inferiorly compared to the original fam map.The approximate difference was 6 mm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.No adverse patient consequence was reported.

Manufacturer Narrative

The hardware investigation was completed on (b)(6)-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.There was an unexplained map shift during the procedure.It was noticed when they were trying to ablate around the left pulmonary vein.They noticed the map didn't line up and that the map had shifted inferiorly.The map shift was confirmed using ultrasound and re famed to continue on with the procedure.Before the map shift occurred, they were unable to use the middle button on the mouse to turn the map as usual.This was temporary and the mouse started working about 2 minutes later.At the end of the procedure, some of the buttons (number keys) on the keyboard also stopped working temporarily for a few minutes before they began to work again.A default template was in use.There was no error reported on the system.When the catheter appeared to be on the inferior side of the lipv, the vector on the smarttouch catheter did not look correct.At that time, the pentaray catheter was moved from the right pulmonary veins to the left pulmonary veins to confirm their location and the position of the veins was shifted inferiorly compared to the original fam map.The approximate difference was 6 mm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.No adverse patient consequence was reported.Hardware investigation details: the bwi field service engineer (fse) confirmed that reboot of system resolved issue.The reported issue and the study data related to the reported issue were investigated by the device manufacturer.It was found that at a certain point, along the study, there was what seemed to be patient movement.While the back patch moved no more than 2mm, the chest patch moved 8-18mm depending on which patch.Looking at the pentaray catheter, it was shifted more than 10mm at the same instance.Warning was not issued as the back patch did not violate the rigid body form, however, the catheter, as well as the heart, moved physically without proper compensation.It was concluded that the map shift occured due to patient move.The issue was found to be related to user error.The system was ready for use.It was also reported that at the end of the procedure, some of the buttons (number keys) on the keyboard also stopped working temporarily for a few minutes before they began to work again.The bwi fse confirmed that the reboot of system resolved this issue.System was ready for use.The history of customer complaints reported during the last year associated with carto 3 system #29110 was reviewed and one additional complaint similar to the reported issue was found.A manufacturing record evaluation was performed for the system #29110, 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14494359
• MDR Text Key: 292758665
• Report Number: 2029046-2022-01125
• 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: 07/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2015
• 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