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

Model Number M-4800-01

Device Problem Positioning Problem (3009)

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

Event Date 05/19/2016

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 during an atrial fibrillation - persistent procedure there was a map shift.The system never asked to perform the learn new action.No error message was provided by the system.The lasso and the smart touch sf catheters were between 3 and 5mm outside the created fast anatomical map (fam).No cardioversion was performed.The patient did not move during the procedure.The procedure was completed with no patient consequence.Since there was no error provided by the system, no cardioversion was performed and the patient did not move during the procedure, this event has been assessed as reportable.The awareness date is may 24, 2016.

Manufacturer Narrative

(b)(4).It was reported that during an atrial fibrillation ¿ persistent procedure there was a map shift.The system never asked to perform the learn new action.No error message was provided by the system.The lasso and the smart touch sf catheters were between 3 and 5mm outside the created fast anatomical map (fam).No cardioversion was performed.The patient did not move during the procedure.The procedure was completed with no patient consequence.The root cause of the issue was determined to be the sedation of the patient that was causing a diaphragm movement and then a chest relaxation that cannot be compensated by carto and causes a sure map shift.After the sedation protocol was modified, the issue did not recur.In addition, the issue was investigated by the device manufacturer.Conclusions: ¿the carto system was performing as expected (no product malfunction).During the case after creation of a map, some sedative drugs were given to the patient which could have caused diaphragmatic relaxation.This may cause a shift of the heart position in the carto z axis, hence leading to an unidentified map shift.This was confirmed with the physician and once a change in the workflow was introduced (giving sedation before initial map is created/ other drugs) this did not recur¿.The system was tested after a supported case by the biosense webster field service engineer, with all the acceptance testing procedures passed.System is operational.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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5721888
• MDR Text Key: 48421674
• Report Number: 3008203003-2016-00021
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• 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: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1