MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00J

Device Problems Break (1069); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2015

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Contact office and manufacturing site should reflect: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system, and the electrical potential was not displayed.It was stated that the ecg in cable was broken and the electrical potential was not displayed.The issue was resolved by reconnecting the cable several times.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, there is no evidence that they were able to monitor the patient's heart rhythm.Lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.Therefore, this event has been assessed as a reportable malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system, and the ecg in cable was broken and the electrical potential was not displayed.The issue was resolved by reconnecting the cable several times.The procedure was completed with no patient consequence.The bs-ecg trunk cable was replaced, and as a result, the problem was resolved.The system is ready for use.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: SIMILAR DEVICE FG540000, 510K # K042999
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5053469
• MDR Text Key: 25886689
• Report Number: 3008203003-2015-00071
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2015

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: FG-5400-00J
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2015
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1