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

Catalog Number FG560000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

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 # (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was initially reported that after ablations had been completed, they went back to create a voltage map and when the re-map was created there was an obvious shift in the re-map.No warnings, alerts, or errors seen on the carto 3 system.No fluoro was in use.The procedure continued with the re-map.There was no patient consequence.The reported map shift issue was initially considered not mdr reportable since there was no information indicating if there was cardioversion or patient movement.On 6/3/2019, biosense webster inc.Received additional information about the event indicating that the approximate difference in catheter location before and after map shift was 1 cm approximate, caudal and anterior.No patient movement detected; patient was under general anesthesia and no cardio-version was performed.It was additionally reported that all the metal values were <2, with a possibility that someone actually moved x-ray c-arm away from field if anything.Thereby reducing metal values.This event was originally considered non-reportable, however, based on the information received on 6/3/2019, the event has been reassessed as mdr reportable as a malfunction since the information indicated the physician did not perform cardioversion, there was no patient movement and there was no error messages given by the system.

Manufacturer Narrative

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was initially reported that after ablations had been completed, they went back to create a voltage map and when the re-map was created there was an obvious shift in the re-map.No warnings, alerts, or errors seen on the carto 3 system.No fluoro was in use.The procedure continued with the re-map.There was no patient consequence.On 6/3/2019, biosense webster inc.Received additional information about the event indicating that the approximate difference in catheter location before and after map shift was 1 cm approximate, caudal and anterior.No patient movement detected; patient was under general anesthesia and no cardio-version was performed.It was additionally reported that all the metal values were <2, with a possibility that someone actually moved x-ray c-arm away from field if anything.Thereby reducing metal values.Device evaluation details: the biosense webster inc.Field service engineer (fse) discussed event with the bwi representative and confirmed that the issue was not duplicated during the following 4 cases.The system was not tested.Fse confirmed that the system is operational.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.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: 8732438
• MDR Text Key: 150165931
• Report Number: 2029046-2019-03322
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG560000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Patient Sequence Number: 1