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

Model Number M-4800-01

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

During an ablation procedure, it was reported there was a map shift during mapping with no error code or alert displayed on the carto 3 system.Map was recreated and the case was completed without any patient consequences.Additional information provided stated the map shift did not occur during rf ablation.The map shift approximately >1mm.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer's reference # (b)(4) during an ablation procedure, it was reported there was a map shift during mapping with no error code or alert displayed on the carto 3 system.Map was recreated and the case was completed without any patient consequences.Additional information provided stated the map shift did not occur during rf ablation.The map shift approximately >1mm.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 device history records (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: 3700812
• MDR Text Key: 17384363
• Report Number: 3008203003-2014-00023
• 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: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• 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: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1