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 10/03/2018

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.Concomitant products: smartablate generator (us catalog # unknown, serial # unknown).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left atrial flutter with a carto 3 system and a ¿map shift¿ issue occurred.There were no patient consequences.During the mapping phase of the procedure, map shifts were observed throughout the procedure.No errors displayed.The map shift was noticed during movement of the diagnostic catheter.There were no patient movements and no cardioversions prior to the map shift.Cable from the patient interface unit (piu) to the smartablate generator was replaced without resolution.Patch unit was replaced without resolution.Smartablate generator was replaced, and the issue seemed to improve but not fully resolve.Underlying cause could not be identified.The patient did not move as the patient was under anesthesia prior to the map shift, the shift was 1-1.5cm, and the map shift did not result in the population of an error message.

Manufacturer Narrative

On (b)(6)2018, additional information about the event was received.It was indicated that the usual work flow before the map shift ever occurred was, one grounding pad connected to smartablate generator and one to baylis.After the transseptal we would switch 2nd grounding pad from baylis to smartablate and proceed with ablation.However, in this instance, we started to ablate a right atrial flutter before going transeptal, and for whatever reason, the tech in the procedure room thought it was necessary to connect 2nd grounding while on ablation which immediately caused it to error and map shift and the physician either came off or smartablate cut off.Based on this new information this complaint is re-assessed as not mdr reportable.According to the additional information, the map shift occurred after a second grounding patch was added during the procedure (after the map was initialized).Per engineer investigation, this action will change the impedance distribution and thus will affect the localization matrix.Therefore, in this case the map shift is not a result of malfunction.However, because this event was already reported to fda, biosense webster inc.(bwi) i will continue to report supplemental mdrs as deemed necessary.Product investigation details: product investigation has been completed.A biosense webster inc.(bwi) field service engineer (fse) was dispatched evaluate the unit.The fse visited the account and checked the system.The fse performed acceptance testing procedures; and all tests passed.The system is ready for use.It was also reported that during troubleshooting, the bwi representative replaced smartablate generator.It was later reported that the user¿s work flow/setup may possibly be off label use of the system.A 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.Management is notified of failure analysis through the monthly trending reports.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: 8020162
• MDR Text Key: 125662769
• Report Number: 2029046-2018-02226
• 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: 10/03/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 12/29/2018
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1