MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000M

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

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 a patient underwent a procedure with a carto 3 system and a map shift issue occurred.It was reported that after the epicardium and both ventricles had been mapped, a significant map shift occurred with no error messages on the carto 3 system.There were eo error message was displayed, no metal interferences and no change of any of the back patches' locations.The map shift was discovered since the sensor enabled catheter appeared outside the acquired geometry and described as somewhere between 1 cm and 3 cm shift.There was no patient movement or cardioversion prior to the shift.The chambers were remapped in order to continue the case.There were no patient consequences.This is event has been assessed as mdr reportable.

Manufacturer Narrative

On 11/6/2018, the manufactured date of the carto 3 system was received.Therefore, device manufacture date has been populated with 6/16/2011.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent a procedure with a carto 3 system and a map shift issue occurred.It was reported that after the epicardium and both ventricles had been mapped, a significant map shift occurred with no error messages on the carto 3 system.There were no error messages displayed, no metal interferences and no change of any of the back patches' locations.There was no patient movement or cardioversion prior to the shift.Device evaluation details: it was reported that the biosense webster inc.(bwi) representative and bwi field service engineer were informed about this issue, but no action was taken since the case was successfully completed.It was also confirmed that no similar issue has been reported since then.The system is operational.A 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 ref # (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8040377
• MDR Text Key: 128248367
• Report Number: 2029046-2018-02245
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1