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); Malposition of Device (2616)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During procedure, a map shift occurred with no error message displayed.There was no patient consequence.The procedure was completed without resolving the issue.The shift was determined by physician as the ablation catheter was placed back in the cs fam that was created earlier and finding the catheter outside of the area.This issue occurred during ablating, approximately a half of a grid (about 5 mm).There was no cardioversion performed and head movement was not likely but possible.This event is being reported since a map shift occurred with no error message shown and potentially be a risk to the patient.As on october 30, 2014 we received information that no error message was given by the equipment, awareness date changed from october 28 to october 30.

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).

Manufacturer Narrative

Please refer to (evaluation summary) for investigation results.Manufacturer's reference # (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During procedure, a map shift occurred with no error message displayed.There was no patient consequence.The procedure was completed without resolving the issue.The shift was determined by physician as the ablation catheter was placed back in the cs fam that was created earlier and finding the catheter outside of the area.This issue occurred during ablating, approximately a half of a grid (about 5 mm).There was no cardioversion performed and head movement was not likely but possible.This event is being reported since a map shift occurred with no error message shown and potentially be a risk to the patient.The investigational analysis has been completed.Field service engineer (fse) advised bwi representative to insure that bcs was acquired when c-arms were in position.Fse informed bwi representative that metal interference from lateral arms can cause a map shift if it was brought in prior to calculation of bcs.Bwi representative acknowledged troubleshooting tips.Fse contacted bwi representative and per discussion, bwi representative reported that the issue was not duplicated on multiple cases on 11/2012.Issue self resolved.No map shift errors were reported.System is functioning normally and is ready for use.A device history record (dhr) 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.The customer complaint was confirmed.

• 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4272228
• MDR Text Key: 5027852
• Report Number: 3008203003-2014-00075
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1