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

Model Number M-4800-01

Device Problems Flushing Problem (1252); Issue With Displayed Error Message (2967); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

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 a right atrial flutter procedure with a carto® 3 system and a map shift without error message occurred.During mapping, there were high temperatures of 43°c being displayed by the catheter.The temperature cutoff was 43°c and the generator stopped ablation when the cutoff was reached.The catheter was removed from the body and it was then noticed that it was not flushing properly.The catheter was replaced and the issue resolved.When the replacement catheter was inserted into the body, it was noticed that the catheter appeared outside the map shell and therefore a map shift had occurred.There was a significant difference in the catheter location before and after the map shift.The new location was higher on the screen than the old one.There were no metal errors or warnings displayed.A new map was created; the procedure was continued and subsequently completed with no patient consequence.This event is mdr reportable because map shifts with no error message could potentially cause a potential risk to the patient.The high temperature and irrigation issue is not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

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 error message occurred.When the replacement catheter was inserted into the body, it was noticed that the catheter appeared outside the map shell and therefore a map shift had occurred.The field service engineer (fse) followed up on the issue with a bwi representative and asked for more information on case details during time of the map shift.Fse supplied bwi representative with patch placement guidelines and actions to take and check when a map shift occurs and referenced "advanced training ".Bwi representative informed fse that following guidelines for map shifts the issue was not duplicated and following cases completed successfully.The system is operational.Device manufacturer requested study data for review; however the study data could not be analyzed because the study data was not available to send for investigation.The 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: 5548253
• MDR Text Key: 42890390
• Report Number: 3008203003-2016-00011
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• 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: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1