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

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

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.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto 3 system and a map shift with no error message occurred.During the case, the map was accurate until it was time for ablation on the right pulmonary veins.The map shift was discovered when the physician went into the right inferior pulmonary vein and saw the lasso was out of the original map by approximately 10mm using the distance tool.There was no error on the carto and the patient did not move before or during the event.The procedure was continued with no patient consequence.This event is mdr reportable because if there is a map shift for which the carto did not display any immediate error or warning message, then there is a potential risk to the patient.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto 3 system and a map shift with no error message occurred.Field service engineer reviewed system log and video file.During movement of catheter from left atrium to right atrium, physician moved c-arm, which caused a significant metal change on chest patches.For example, the wrong current position mapping collection.Due to wrong current position mapping collection, later visualization of lasso catheter was shifted from the previous position.This issue is related to a bug.There is a map shift without any notification to user in some cases.This issue is noted to the user in the release notes.System is fully functional and ready for clinical use.Device history record 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.Manufacturing date for carto 3 with serial # (b)(4) is december 21, 2015.Manufacturer's ref.No: (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: 7242236
• MDR Text Key: 99097053
• Report Number: 2029046-2018-01109
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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: 01/11/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1