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

Catalog Number FG540000

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

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 procedure for paroxysmal atrial fibrillation with a carto 3 system where there was a procedure delay.At the beginning of the case, there was a communication error with the carto.It took over an hour for the unit to properly initialize.This resulted in an hour long case delay, but the procedure was able to be successfully completed with no patient consequences reported.The physician had already performed the transseptal puncture, and the sheath (st.Jude medical sl0) was inside the left atrium while waiting for the carto system to initialize.During this time, the patient was anticoagulated and being monitored.The physician assessed the delay as a potential risk, as the patient had already been anticoagulated and had the transseptal performed.As a result, this event is mdr reportable.

Manufacturer Narrative

Additional information was received january 24, 2018.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.Product complaint # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where there was a procedure delay.At the beginning of the case, there was a communication error with the carto.It took over an hour for the unit to properly initialize.This resulted in an hour-long case delay, but the procedure was able to be successfully completed with no patient consequences reported.Product investigation summary: the biosense webster inc.(bwi) field service engineer (fse) replaced the patient interface unit (piu) and resolved reported issue.Annual maintenance was also performed successfully.System is ready for use.The replaced piu was sent to the device manufacturer for investigation/repair.The device manufacturer concluded the customer complaint was confirmed.The dc/dc card in the piu was found to have failed and causing the communication issue.The dc/dc card was repaired and the piu returned to normal function.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: 7200806
• MDR Text Key: 97964097
• Report Number: 2029046-2018-01081
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1