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

Model Number M-4800-01

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

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 reentrant tachycardia (avrt)/(wpw) procedure with a carto 3 system.The carto 3 system application restarted on its own.It was also reported that there was a map shift.No active troubleshooting could be performed.The procedure was completed successfully with no patient consequence.Additional information was requested and received on the event.No error message populated for the map shift.The shift was noticed when the catheter appeared outside the map during mapping.The new locations appeared to be about one centimeter north or superior to the previous map.No cardioversion was performed.The patient was under general anesthesia.The issue with the device restarting was assessed as not reportable.It is a highly detectable issue.The potential risk that it could cause or contribute to a death or serious deterioration in the patient¿s state of health was remote.The issue with the map shift with no error message was assessed as reportable.Such map shifts could potentially be caused by a system malfunction, and there was a potential risk to patient.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with a carto 3 system.It was reported that the carto 3 system application restarted on its own.Software crash.No data loss was reported.The procedure was continued after restart.The history of customer complaints associated with this specific system were reviewed and it was found that the issue was not reported anymore.System is operational.It was also reported that there was a map shift.No active troubleshooting could be performed.The procedure was completed successfully.The biosense webster field service engineer completed the full system test in accordance with atp.All tests passed.System is operational.The biosense webster field service engineer followed up with biosense webster representative and confirmed that after weeks of procedures, this issue was not duplicated.System is ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate the carto 3 sw crashes.

• 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: 6670916
• MDR Text Key: 78597143
• Report Number: 3008203003-2017-00026
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1