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 11/13/2018

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 (afib) procedure with a carto® 3 system and a map shift occurred with no error message and no patient movement or cardioversion.Initially it was reported that the screen of the workstation was frozen.It was then restarted.The catheter was moving in a strange way and the map shifted.A new study was started.The issue resolved.There was no patient consequence reported.Multiple attempts had been made to obtain clarification to this complaint.However, no further information was made available.Therefore, the map shift was assessed as not reportable.There was no information to indicate that there was no error message and that there was no patient movement or cardioversion.Also, the issues of the catheter visualization and the screen of the workstation was frozen were assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The map shift issue was originally considered non-reportable, however, bwi became aware on (b)(4) 2018 that the map shift occurred during mapping.The approximate shift was 2cm.There was no patient movement or cardioversion prior to the map shift.There was no error message on the carto® 3 system.Since there was no patient movement or cardioversion and there was no error message that populated on the system, this issue is reassessed to a reportable malfunction.The awareness date is (b)(4) 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system.It was reported that the screen of the workstation was frozen.It was then restarted.The catheter was moving in a strange way and the map shifted.A new study was started.The issue resolved.There was no patient consequence reported.Additional information was received stating that the map shift occurred during mapping.The approximate shift was 2cm.There was no patient movement or cardioversion prior to the map shift.There was no error message on the carto® 3 system.An investigation was opened with the device manufacturer in order to investigate the map shift issue.Data was requested and was not received.Customer advised that issue has not occurred since this case.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).

Manufacturer Narrative

Additional information was received on january 21, 2019, providing the manufactured date.Therefore, populated the device manufacture date.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: 8265896
• MDR Text Key: 133688501
• Report Number: 2029046-2019-02592
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• 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: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1