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

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

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: thermocool smart touch bidirectional sf catheter, catalog # d134805, lot # 17740163l unspecified lasso catheter.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where a map shift occurred.Prior to the map shift, a force sensor error populated while a smart touch catheter was in the right atrium.A cable change did not resolve the issue, so the catheter itself was exchanged.The error message cleared.In the event of a force sensor error, the catheter cannot be used and must be changed.The potential that this could cause or contribute to an adverse event is remote.As a result, this event is not mdr reportable.Later in the case, after mapping of the left atrium was completed and ablation had been initiated, the physician noticed a slight map shift (approximately 10mm anteriorly).The shift was confirmed by maneuvering a lasso catheter through the right inferior and superior pulmonary veins.The physician noted that there was no patient movement, and no cardioversion was performed.A new map was built, and the case was completed without patient consequence.A map shift occurring without patient movement/cardioversion that doesn¿t generate an error message present a potential risk to the patient, making this event mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where a map shift occurred.Prior to the map shift, a force sensor error populated while a smart touch catheter was in the right atrium.A cable change did not resolve the issue, so the catheter itself was exchanged.The error message cleared.Later in the case, after mapping of the left atrium was completed and ablation had been initiated, the physician noticed a slight map shift approximately 10mm anteriorly).The shift was confirmed by maneuvering a lasso catheter through the right inferior and superior pulmonary veins.The physician noted that there was no patient movement, and no cardioversion was performed.A new map was built, and the case was completed without patient consequence.Product investigation summary: a biosense webster inc.(bwi), field service engineer (fse) investigated the issue and found that map misalignment was caused by faulty eco cable.The defective eco cable was replaced.The data related map misalignment was provided to the device manufacturer and investigated further.The device manufacturer's conclusion stated that it was found that this map misalignment was caused by changing metal values on the lasso catheter, resulting in inaccurate cpm collection during fast anatomical mapping (fam) creation.It was caused by a faulty eco dongle cable.The metal value was below alert limit, as a result there was no indication for map shift issue.For issues related to "map shift without any notification to user" the device manufacturer is working on a solution.The system is ready for use.Device history review (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: 7182699
• MDR Text Key: 97738928
• Report Number: 2029046-2018-01046
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)151221
• 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
• Report Date: 12/21/2017

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: 12/21/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1