MAUDE Adverse Event Report: BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, it was reported that there was a map shift during mapping with no patient movement and no alert displayed on the carto® 3 system.The procedure was completed conventionally without any patient consequence.On (b)(6) received additional information requested from bwi representative stating that the map shift was approximately 6 (six) millimeters.As there were no error message for the map shift issue, this may be a potential risk to the patient.Therefore, this complaint became reportable.

Manufacturer Narrative

A) the investigation is still in progress.(b)(4).

Manufacturer Narrative

Please refer to section h3 (evaluation summary) for investigation results.Manufacturer's reference # (b)(4) during an atrial fibrillation procedure, it was reported that there was a map shift during mapping with no patient movement and no alert displayed on the carto® 3 system.The procedure was completed conventionally without any patient consequence.A device manufacturer (htc) representative visited the hospital and investigated the issue.The issue was reproduced.It was found that it was caused by workflow (wf): cine/ image were taken with sensor-based catheter distant from the area of interest, and as a result the image was applied to the carto 3 space in an inaccurate area, causing difference between the carto map and fluoro image taken.Htc representative has advised on improved wf.Once proposed wf was implemented, next cases passed without issues and the system is operational.This issue was escalated for preventive action.The dhr associated with carto 3 # 13453 was reviewed and there were not any discrepancies noted.The system met all specifications upon its release.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3699275
• MDR Text Key: 4228416
• Report Number: 3008203003-2014-00020
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1