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 10/31/2016

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 procedure with a carto 3 system.It was reported that while mapping with the carto 3 system, when the catheter was moved and returned to a previous location, the location tags were misaligned.The position of the catheter on the carto 3 system and fluoroscopy were misaligned.There were no error messages and the metal values were within normal limits.The map shift was estimated at approximately 2.5 cm.It was not known if a cardioversion was performed or if there was patient movement to explain the map shift.The procedure was completed using the system with this issue.There were no patient consequences.This event was assessed as a reportable malfunction as 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 procedure with a carto 3 system.It was reported that while mapping with the carto 3 system, when the catheter was moved and returned to a previous location, the location tags were misaligned.The position of the catheter on the carto 3 system and fluoroscopy were misaligned.There were no error messages and the metal values were within normal limits.The map shift was estimated at approximately 2.5 cm.It was not known if a cardioversion was performed or if there was patient movement to explain the map shift.The procedure was completed using the system with this issue.There were no patient consequences.It was reported that the customer declined repair.The system was returned to customer by request of the customer.It was also reported that the system is functional.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.

• 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: 6123338
• MDR Text Key: 61022009
• Report Number: 3008203003-2016-00039
• 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: 10/31/2016

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 Model Number: FG-5400-00K
• Device Catalogue Number: FG540000K
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1