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

Model Number M-4800-01

Device Problem Device Alarm System (1012)

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

Event Date 02/16/2016

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 and a slight map shift with no error message occurred while using a voltage map in confidense.The catheter did not seem to line up with the pulmonary veins like it had previously.The approximate difference in the catheter location before the map shift was about 5mm.No active troubleshooting was performed.The procedure was completed successfully with no patient consequence reported.Since this map shift occurred with no error message and there was no patient movement reported, this type of map shift could potentially be caused by a system malfunction and there would be a potential risk to the patient.Therefore, this issue is being assessed as a reportable malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a slight map shift with no error message occurred while using a voltage map in confidence.No active troubleshooting was performed.The procedure was completed successfully with no patient consequence reported.The biosense webster field service engineer followed up the issue with biosense webster field representative.The biosense webster field representative uploaded data for investigation to the device manufacturer server (mbox).The delivered study data was found corrupted and could not be analyzed by the device manufacturer.On the additional request, the biosense webster field representative informed that the files are no longer on the carto 3 workstation.The biosense field representative does not have a saved copy to mail.The biosense field service engineer was informed that the following procedure was fine and the issue was not duplicated.The 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: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 ; 9497893837
• MDR Report Key: 5485381
• MDR Text Key: 40261294
• Report Number: 3008203003-2016-00006
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 02/16/2016

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: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1