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

Model Number M-5830-01

Device Problems Device Displays Incorrect Message (2591); Malposition of Device (2616)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 rmt system and a map shift no error message occurred.It was reported that there was a map shift.The c shift was considered very dramatic and occurred for no reason.There was no equipment moving in the room and the patient did not move.The caller stated that the patient was not defibrillated.The procedure was completed without using the map.There was no patient consequence.Upon request, additional information was provided on the event.The map shift occurred during ablating.When the map shift occurred there was no error.It was discovered by intracardiac electrocardiogram (ice) and fluoroscopy.The difference in the catheter location before and after the map shift was 4cm.

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).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 rmt system and a map shift no error message occurred.System tests were performed.All tests passed.Case support completed without any issues.The issue was not duplicated.The system is ready for use.The history of customer complaints associated with carto 3 system was reviewed.Out of 36 additional reported complaints there was not any additional complaint that may be related to the reported issue.Dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO 3 RMT 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4561186
• MDR Text Key: 5560822
• Report Number: 3008203003-2015-00010
• 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: 02/09/2015

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-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1