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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the visitag module had disappeared and there was no error displayed.The visitag investigation is in process to determine patient risk when not functioning properly; however that investigation is not complete.Therefore, in taking a conservative approach this event has been assessed as reportable.In addition, it was reported that the customer received magnetic sensor error (error 0 code 105) on the lasso catheter, and noise on poles 1 & 2 on the smart touch catheter.By changing the catheters, these issues were resolved and the case was completed without any patient consequence.These two issues are not reportable malfunctions.

Manufacturer Narrative

(b)(6).The concomitant products: lasso nav variable eco, model#d-1343-01-s, lot# 17155756l.Smart touch bidirectional model#d-1327-04-s, lot#17156486m.(b)(4).

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that during an atrial fibrillation (afib) procedure, the visitag module was disappeared and there was no error displayed.In addition, it was reported that the customer received magnetic sensor error (error 0 code 105) on the lasso catheter, and noise on poles 1 & 2 on the smart touch catheter.By changing the catheters, these issues were resolved and the case was completed without any patient consequence.It was confirmed that the issue was resolved by rebooting the workstation and the issue was not duplicated during next case.The system worked properly with no issues.The system is ready for use.Device history record (dhr) was 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 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4770345
• MDR Text Key: 5950576
• Report Number: 3008203003-2015-00030
• 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: 04/16/2015

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-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1