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

Catalog Number FG540000

Device Problem No Pacing (3268)

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.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system and a pacing issue occurred while engaged in emergency pacing.There were issues with pacing capabilities in the ref deca port and the mapping port.The catheter cable was replaced, and the issue remained.The catheter was moved to 20a port to proceed with the case and finish successfully.Additionally, it was reported that the pacing leads were connected to the pacing ports and direct ports.Pacing was both planned and emergency with no unwanted pacing being delivered.A bloom stimulator was used during the procedure.No patient consequences were reported.The event has been reviewed and assessed as mdr reportable.

Manufacturer Narrative

On(b)(6)2018 , the date of manufacture was recieved from the manufacture as 9/26/2011.Device manufacture date.Device manufacture date has been added.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system and a pacing issue occurred while engaged in emergency pacing.There were issues with pacing capabilities in the ref deca port and the mapping port.The catheter cable was replaced, and the issue remained.The catheter was moved to 20a port to proceed with the case and finish successfully.Device evaluation details: the device evaluation has been completed.It was reported the catheter was moved to 20 a port to proceed with the case and finished successfully.The field service engineer (fse) tested the carto 3 system and couldn't duplicate the issue.The fse re-imaged the workstation as preventive action.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 ref # (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: 8144660
• MDR Text Key: 130061771
• Report Number: 2029046-2018-02425
• 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,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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: 01/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1