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

Catalog Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

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 ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and there was a map shift with no error message and no patient movement or cardioversion.It was noted that there was a map shift and the patient and patches had not moved.No error codes were displayed.The procedure was continued onto the left side.No patient consequences were reported.Additional information was received stating that the physician noticed the map shift when he tried to get back to a certain location.The issue was seen during ablation.The map shift with no error message and no patient movement or cardioversion was assessed as a reportable issue.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.It was noted that there was a map shift and the patient and patches had not moved.No error codes were displayed.The procedure was continued onto the left side.No patient consequences were reported.Additional information was received stating that the physician noticed the map shift when he tried to get back to a certain location.The issue was seen during ablation.The biosense webster field service engineer advised that the map shift was due to the lab environment, restarting the system reset the visualization and the issue was resolved.The device history record review (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.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: 8393164
• MDR Text Key: 141471742
• Report Number: 2029046-2019-02751
• 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: 02/11/2019

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 Catalogue Number: FG540000
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1