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

Model Number FG-5400-00J

Device Problem No Pacing (3268)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

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.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto system and pacing could not be achieved connected to the piu nor the emergency ports.No error codes were displayed by the system at that time.The issue persisted even though troubleshooting was conducted.Therefore, the use of carto system was abandoned and procedure was finished conventionally without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is being reported because direct pacing port failure can potentially delay treatment and contribute to an adverse event.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto® 3 system and pacing could not be achieved connected to the piu nor the emergency ports.No error codes were displayed by the system at that time.The issue persisted even though troubleshooting was conducted.Therefore, the use of carto system was abandoned and procedure was finished conventionally without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is being reported because direct pacing port failure can potentially delay treatment and contribute to an adverse event.The investigational analysis has been completed.The system was checked by fse, but no problems were found.Functional test and electronical safety test were passed.The system is working fine.The history of customer complaints associated with carto 3 system # 50192 was reviewed.2 out of 5 additional reported complaints 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 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: 4912253
• MDR Text Key: 22386078
• Report Number: 3008203003-2015-00054
• 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
• Report Date: 06/26/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1