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 04/20/2018

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 an paroxysmal atrial fibrillation procedure with carto® 3 system and during the ablation, signal loss and noise on all electrocardiogram (ecg) channels occurred.A current leakage error was displayed.Followed by, signal loss on all channels including the intracardiac, body surface, carto 3, surveillance monitor, recording system, and defibrillator ecg.Then noise became visible on all channels.The ablation catheter was replaced and the issue persisted.The ablation adapter cable was replaced and the signal issue resolved.The current leakage error was cleared on the carto 3 system by pressing the reconnect button.All signals then reappeared and the procedure was continued.Customer could not confirm if the defibrillator ecg and surveillance monitor ecg signals reoccurred upon disconnection of ablation catheter as attention was payed to carto and ep recording system.Upon loss of signals and during troubleshooting the patient was monitored using invasive and non-invasive blood pressure measurements as well as non-invasive pulse measurement.During ablation, no external signals were available to monitor the patient's heart rhythm.Therefore, this event has been assessed as a reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an paroxysmal atrial fibrillation procedure with carto® 3 system and during the ablation, signal loss and noise on all electrocardiogram (ecg) channels occurred.The investigational analysis has been completed.Field service engineer (fse) discussed with customer service specialist (css) and advised replacement of the ablation adaptor cable.Replacement of the ablation adaptor cable was then delivered to the account.Once the defective cable was replaced, the issue resolved.System was then operational.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.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: 7504723
• MDR Text Key: 108292671
• Report Number: 2029046-2018-01534
• 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
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1