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 04/27/2022

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.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 supraventricular tachycardia (svt) ablation procedure with a carto® 3 system and there was a map shift with no error message, no patient movement and no cardioversion performed issue occurred.Initially it was reported that the carto® 3 system restarted without warning.No error codes displayed.When the study was re-entered, there was a map shift.A new map was restarted and the procedure was continued and subsequently completed.Additional information was received on 28-apr-2022.The map shift was discovered when a window popped up saying carto needed to reinitialize.No error codes appeared.Patient did not move nor did the bed (bed was raised far from fluoroscopy and the magnet values were fine).The issue was seen during mapping and the approximate difference in catheter location before and after map shift was about 5mm.Attempts were made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this event was assessed as not mdr reportable for this map shift issue and software crash issue.Additional information was received on 10-may-2022 stating that the patient was not cardioverted.Per the additional information received stating that the patient was not cardioverted, the map shift issue with no error message, no patient movement and no cardioversion performed was reassessed to mdr reportable.The awareness date for this reportable issue is 10-may-2022.

Manufacturer Narrative

The investigation was completed on 10-aug-2022.It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a carto® 3 system.It was reported that the carto® 3 system restarted without warning.No error codes displayed.When the study was re-entered, there was a map shift.The map shift was discovered when a window popped up saying carto needed to reinitialize.Patient did not move nor did the bed (bed was raised far from fluoroscopy and the magnet values were fine) and the patient was not cardioverted.The issue was seen during mapping and the approximate difference in catheter location before and after map shift was about 5mm.A new map was restarted and the procedure was continued and subsequently completed.The issue was investigated.It was found that the reported map shift was caused due to patient movement.According to the carto 3 instructions for use: "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated".The complaint history of the system was reviewed.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14482963
• MDR Text Key: 295814231
• Report Number: 2029046-2022-01109
• 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: 09/01/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2021
• 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