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

Catalog Number FG540000

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system.A map shift occurred during afib and right flutter line procedure.No patient consequences were reported.A response was received which confirmed that no error displayed on the carto® 3 system.It also confirmed that no cardioversion or patient movement occurred prior to the map shift.The catheter location difference before and after the map shift was described as the right veins were higher and anterior.Since this map shift did not display an error message on the carto® 3 system, this event has been assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system.A map shift occurred during afib and right flutter line procedure.No patient consequences were reported.A response was received which confirmed that no error displayed on the carto® 3 system.It also confirmed that no cardioversion or patient movement occurred prior to the map shift.The catheter location difference before and after the map shift was described as the right veins were higher and anterior.The biosense webster field service representative replaced the patient interface unit (piu) and the location pad (lp) in order to show the customer that the system was okay, and the shift was caused by fluoroscopy.The system was operational.The data for investigation was provided to the device manufacturer.The device manufacturer¿s conclusion: during the procedure, when moving from the left atrium to the right atrium, as far as it can be seen from the data, the customer moved the fluoroscopy too close to the system, the same when returned back to the left atrium.This proximity caused electromagnetic interference (metal) effect and these manipulations caused the map shift.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.Manufacturer's reference number: (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: 7329626
• MDR Text Key: 102196645
• Report Number: 2029046-2018-01311
• 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
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2018
• 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: 07/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1