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 09/21/2018

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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a carto® 3 system and when a second indifferent electrode was connected to the smartablate generator during radiofrequency delivery, a map shift occurred.The indifferent electrode was removed, and the map shift seemed to correct itself.The electrode was reconnected again; in stand-by mode.The map shift occurred again, moving the map 1.5 cm.The procedure was successfully completed without patient consequences.The map shift issue was seen during both mapping and ablating and the system did not display any error or alert messages when the map shift occurred.The map shift was noticed because the location of the coronary sinus catheter relative to the snapshot was off, and the lasso was outside of the pulmonary vein sound contour.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The map shift, no error message, no patient movement/cardioversion issues have been assessed as reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a carto® 3 system and when a second indifferent electrode was connected to the smartablate generator during radiofrequency delivery, a map shift, no error message, no patient movement/cardioversion occurred.The investigational analysis completed 11/6/2018.The biosense webster inc.(bwi) field service engineer (fse) spoke with the bwi representative and recommended to not connect the "baylis" indifferent electrode into the smartablate generator.The recommendation corrected the user error issue.The system was ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies, which were related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer 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: 7979220
• MDR Text Key: 124145768
• Report Number: 2029046-2018-02184
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 12/04/2018
• Patient Sequence Number: 1