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

Model Number M-4800-01

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

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 right atrial flutter procedure with a carto® 3 system and a map shift without an error message was experienced as well as a 30 minute delay.The procedure was completed with the same map without patient consequence.Additional information was requested to clarify the event and it was informed that all the points of ablation were outside of the shell that was built at the beginning of the case.Regarding the 30 minute delay the physician did not consider this a risk, which is not indicative of an mdr reportable event.This event is being reported because such map shifts potentially caused by system malfunction could mislead the physician and possesses a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a right atrial flutter procedure with a carto® 3 system and a map shift without an error message was experienced as well as a 30 minute delay.The procedure was completed with the same map without patient consequence.Additional information was requested to clarify the event and it was informed that all the points of ablation were outside of the shell that was built at the beginning of the case.Regarding the 30 minute delay the physician did not consider this a risk, which is not indicative of an mdr reportable event.This event is being reported because such map shifts potentially caused by system malfunction could mislead the physician and possesses a potential risk to the patient.The investigational analysis has been completed.The data has been sent to device manufacturer (b)(4) and the issue was investigated by (b)(4).Following information has been received from r&d center (investigation cmf#(b)(4)): the main reason for the map misalignment is high metal value recorded on mapping catheter.Fluoro sid position during the case was very close to the catheter.Taking into account both facts (high and dynamic metals on smarttouch sensor) and low sid during the case we can assume that the issue has been caused by very closed position of fluoro to the catheter sensor.R&d suggested on the steps that should be performed on the site to eliminate this issue in the future.System is fully functional and can be clinically used.The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore no capa activity is required.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5021252
• MDR Text Key: 24702169
• Report Number: 3008203003-2015-00066
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1