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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an paroxysmal atrial fibrillation (afib) procedure with a carto 3 system and there was a map shift with no error message.There was no patient movement.The shift was discovered when cannulating the pulmonary vein and the catheter image appeared entirely out of the fast anatomical mapping (fam) shell of the desired vein.The approximate difference was 2 to 4 centimeters in the catheter location before and after the map shift.The catheter was confirmed to be in the vein via fluoroscopy and intracardiac echocardiography (ice) imaging.This issue occurred when the stereotaxis was used in conjunction with the carto 3 system and the magnets did not move.The issue spontaneously resolved.The procedure was completed with no patient consequence such map shifts with no error message are a potential risk to the patient.Therefore, this event has been assessed as reportable.

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

(b)(4).It was reported that a patient underwent an paroxysmal atrial fibrillation (afib) procedure with a carto 3 system and there was a map shift with no error message.There was no patient movement.The shift was discovered when cannulating the pulmonary vein and the catheter image appeared entirely out of the fast anatomical mapping (fam) shell of the desired vein.The approximate difference was 2 to 4 centimeters in the catheter location before and after the map shift.The catheter was confirmed to be in the vein via fluoroscopy and intracardiac echocardiography (ice) imaging.This issue occurred when the stereotaxis was used in conjunction with the carto 3 system and the magnets did not move.The issue spontaneously resolved.The procedure was completed with no patient consequence the bwi field service engineer contacted the bwi field representatives regarding the issue.The issue was not duplicated.The data was sent to the device manufacturer to perform data analysis.The device manufacturer received the data but it was corrupted.The device manufacturer requested to resend the data, but the bwi field representatives nor the bwi field service engineer had the exported files.Therefore, the data was not investigated and the root cause of the failure could not be determined.The history of customer complaints associated with this specific problem was reviewed and the issue was not reported anymore.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: shahe garabedian ; 9098397362
• MDR Report Key: 4883848
• MDR Text Key: 6266065
• Report Number: 3008203003-2015-00047
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2015

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: 06/05/2015
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1