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

Catalog Number FG540000

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

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 procedure with carto® 3 system and a current leakage error 7 and noise on all electrocardiogram (ecg) signals occurred.Earlier in the procedure there was a temperature issue which resolved when the catheter was exchanged.After that, a current leakage error 7 displayed on the carto.In addition to the current leakage error, there was a signal interference on the intracardiac and body surface channels, as well as the carto and recording system.There were no ecg signals available for the physician to monitor the patient¿s heart rhythm.The patient interface unity was restarted without being connected to the cable and catheter, and the issue resolved.The case continued without further incident or patient harm.Temperature issue is not reportable, as user selected cut-off was never exceeded.However, since the physician had no ecg signal available to monitor the patient¿s heart rhythm during the signal interference issue, this event has been assessed as a reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with carto® 3 system and a current leakage error 7 and noise on all electrocardiogram (ecg) signals occurred.The investigational analysis completed on 12/5/2018.It was advised to restart the patient interface unit (piu) without catheters and cables connected.Upon reboot the piu and connecting the ablation cable the case continued without further incident or harm.Biosense webster inc.(bwi) field service engineer (fse) performed preventative maintenance and completed acceptance testing on carto 3 system.All tests passed.No additional service was requested by the customer.The system was 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.Manufacture reference no: (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: 7526775
• MDR Text Key: 108731827
• Report Number: 2029046-2018-01566
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1