MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00K

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.During ablation it was noted that there was a location difference between the right pulmonary vein map at anterior half of the procedure and the catheter placement at the right pulmonary vein at the end of the procedure.The amount of the shift was not known.There was no error message observed.It could not be confirmed if there was any patient movement or a cardioversion prior to the shift.The issue did not improve but the procedure was continued and completed without the map and the location of the catheter.There was no patient consequence.This event is being conservatively reported as the response received could not confirm patient movement or cardioversion prior to the shift.Such map shifts could potentially be caused by system malfunction and there would be a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.During ablation it was noted that there was a location difference between the right pulmonary vein map at anterior half of the procedure and the catheter placement at the right pulmonary vein at the end of the procedure.The amount of the shift was not known.There was no error message observed.It could not be confirmed if there was any patient movement or a cardioversion prior to the shift.The issue did not improve but the procedure was continued and completed without the map and the location of the catheter.There was no patient consequence.The biosense webster field service engineer reported that the issue was not reproduced during the troubleshooting on site.Atp tests were performed and passed.The green patch sensor cable was replaced as a preventive action.The yellow patch sensor cable was found damaged and was replaced too.System is operational.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6175115
• MDR Text Key: 62864532
• Report Number: 3008203003-2016-00044
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-5400-00K
• Device Catalogue Number: FG540000K
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1