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 09/18/2020

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) ablation procedure with a carto® 3 system, and a map shift with no error message, no patient movement, and no cardioversion occurred.Initially it was reported that they got a map shift on the carto 3 system.The system did not show any error messages or metal warnings.No patient consequences were reported.Attempts were made to obtain clarification to this complaint.However, no further information had been made available.With the information available, this map shift was assessed as not mdr reportable as there was a map shift without an error message, however, change of the patient's posture or cardioversion was not clearly excluded.Additional information was received on the event on (b)(6) 2020.Map shift of about 3-5mm was noticed in the carto® 3 system while mapping the right veins for isolation.The system did not show any error messages.No cardioversion or patient movement occurred prior to the map shift.Per the additional information clarifying that there was a map shift with no error message, no patient movement and no cardioversion was assessed as mdr reportable.The awareness date is 9/21/2020.

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2020: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.Initially it was reported that they got a map shift on the carto 3 system.The system did not show any error messages or metal warnings.No patient consequences were reported.Additional information was received on the event on (b)(6) 2020.Map shift of about 3-5mm was noticed in the carto® 3 system while mapping the right veins for isolation.The system did not show any error messages.No cardioversion or patient movement occurred prior to the map shift.The study data that was related to the reported issue was investigated by the device manufacturer.It was found that the points and fast anatomical mapping were acquired under high alternating metal distortion and it caused the map shift.However, the level of metal distortion was below the designed warning threshold and as result, the system did not alert user.The biosense webster, inc.Field representative was informed that the biosense webster, inc.Representative rebooted both the workstation and the patient interface unit.The issue was resolved.The system is up and ready for use.A manufacturing record evaluation was performed for the finished device 29160 number, and no internal actions related to the complaint was found during the review.An internal corrective action has been opened to investigate the map shift issue.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: 10691389
• MDR Text Key: 211744868
• Report Number: 2029046-2020-01496
• 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: 09/18/2020

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: 09/21/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1