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 07/10/2018

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.This carto 3 system was manufactured before september 24, 2016, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's ref: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system.During ablation, a map shift occurred.No error messages displayed.There was no patient movement or cardioversion prior to the map shift.A new map was created and the case continued.There were no patient consequences.Approximate difference in catheter location before and after the map shift was 3 cm.Metal values did not change.Patch icons and magnet did not move.This map shift with no error message was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system.During ablation, a map shift occurred.No error messages displayed.Approximate difference in catheter location before and after the map shift was 3 cm.Metal values did not change.Patch icons and magnet did not move.There was no patient movement or cardioversion prior to the map shift.A new map was created and the case continued.There were no patient consequences.The biosense webster field service engineer confirmed with biosense webster field representative that starting a new map resolved the issue.No issues occurred during subsequent procedures.System is ready for use.The device history record (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: 7765687
• MDR Text Key: 116543042
• Report Number: 2029046-2018-01924
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 09/14/2018
• Patient Sequence Number: 1