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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a right sided atrial flutter procedure with carto® 3 system and a map shift with no error message occurred.During mapping, error 8 ¿stimulation routing is disabled¿ was displayed on the carto 3 system.A prompt requesting transfer to a website was displayed.The website request was declined and the screen returned to the map, but it was discovered that a map shift had occurred.In the right atrium (ra) map, the ablation catheter appeared to be outside of the map at the roof of the ra.Both the physician and bwi representative present recognized the map shift.The map shift was not related with pacing issues.There were no error messages displayed regarding the map shift.There was no cardioversion or patient movement prior to the map shift.Deleting the custom map in use, rebooting the carto and creating a new map resolved the issue.The procedure was completed with no patient consequences.The issue with pacing is not mdr reportable because the potential that this issue could cause or contribute to a death or serious deterioration in the patient¿s state of health is remote.The map shift is mdr reportable because no error message relating to a map shift was noted on the carto system.If there is no error message the map shift could be potentially caused by system malfunction, and there is a potential risk to patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a right sided atrial flutter procedure with carto® 3 system and a map shift with no error message occurred.Field service engineer (fse) contacted the biosense webster inc.(bwi) representative and recommended to delete the custom templates, reboot the system and create a new template.Fse confirmed that the deleting custom template and creating a new one resolved all reported issues, and account successfully completed multiple cases without any issues.System is in service and ready for use.Device history record 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: 6287282
• MDR Text Key: 66439982
• Report Number: 3008203003-2017-00003
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• 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: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1