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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, there was a map shift without any warning message from carto before the shift.The map shift occurred during movement of fluoro.Both the magnetic navigation catheter and the acl catheter moved relative to the map in the same direction and the same amount of shift.Approximately, the map shift was 5-10mm.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an atrial fibrillation (afib) procedure, there was a map shift without any warning message from carto before the shift.The map shift occurred during movement of fluoro.Both the magnetic navigation catheter and the acl catheter moved relative to the map in the same direction and the same amount of shift.Approximately, the map shift was 5-10mm.Biosense field service engineers visited account and tried to reproduce the metal interference.Biosense field service engineers could not duplicate the metal changes as described.The data related to the issue was sent to the carto manufacturer (htc) and was analyzed by the responsible engineer.According to the carto manufacturer (htc) customer support expert, a root cause for this issue can't be found based on the received data.Only the log file was received.Recording files were requested, but the needed files couldn't be provided as the workstation was already re-imaged.Since the biosense field service engineers didn't reproduce the reported problem during troubleshooting and additional investigation could not be performed by the carto manufacturer (htc), the repair will be closed as not duplicated.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.The customer requested that the biosense field service engineers evaluate the unit since after map shift the workstation had sluggish performance.Biosense field service engineers visited account and the customer would like the workstation re-imaged to see if that helps with the performance.Re-image failed, so biosense field service engineers requested a replacement workstation.Workstation was replaced.System is running normally and is ready for use.The suspicious workstation was tested and reported that during testing it is found no issues with workstation.The workstation was re-imaged and sent to warehouse as good and ready for use.An additional original external manufacturer (oem) action (dhr review) was performed.The device history record review was performed.No anomalies were noted in manufacturing or service of this device.The system met all specifications upon its release prior to distribution.

• 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: 3628773
• MDR Text Key: 4178821
• Report Number: 3008203003-2014-00010
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• 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: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1