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

Model Number M-4800-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Respiratory Distress (2045)

Event Date 10/11/2016

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 an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system.There were two map shifts during the procedure with no error message.Cardioversion's were not performed prior to the map shifts.There was also no patient movement.The patient was breathing irregularly and the respiratory gating had not been completed.The procedure was completed with no patient consequence.Although irregular patient breathing was noted, it could not be concluded that the irregular breathing was causing movements that would create a mapshift.Therefore, this event is being conservatively assessed as a reportable malfunction.Map shifts without patient movement and no error message could potentially be caused by a system malfunction and there would be a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system.There were two map shifts during the procedure with no error message.Cardioversion's were not performed prior to the map shifts.There was also no patient movement.The patient was breathing irregularly and the respiratory gating had not been completed.The procedure was completed with no patient consequence.The issue was not duplicated.The biosense webster field service engineer went on site and tested the system.The biosense webster field service engineer completed the mag and acl tests in response to the map shift issue.The biosense webster field service engineer also completed full preventative maintenance while on site.All tests passed.The system was 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: 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6076796
• MDR Text Key: 59463519
• Report Number: 3008203003-2016-00036
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1