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

Model Number M-4800-01

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/22/2016

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

Event Description

It was reported that during mapping of the left atrium during the atrial fibrillation procedure, there was map shift.The physician was using a lasso catheter and an ablation catheter.The map shift happened after the ablation.The catheters were out of the map.The position was checked using the fluoroscopy.The physician was not sure why it occurred.The physician thought it may have occurred from metal interference from fluoroscopy, or maybe the location pad was bumped or maybe there was patient movement.The procedure was completed with no patient consequence.Later, it was noted that the issue was related to ineffective anesthesia given to the patient.The map shift described was assessed as not reportable as map shift due to a patient movement with change of posture, or following a cardioversion, even if no error message present is highly detectable and a normal or expected response from the system.Additional information was provided on (b)(6) 2016 stating that there were no error messages given by the carto system.Also after further review, it was clarified that the ineffective anesthesia given to the patient was referring to a separate procedure which was documented under another complaint.Therefore, per the additional clarification received on (b)(6) 2016 stating that there were no errors given by the carto system and no information if there was any patient movement on this event, this event has now been assessed as reportable.The awareness date is reset to (b)(6) 2016.

Manufacturer Narrative

(b)(4).It was reported that during mapping of the left atrium during the atrial fibrillation procedure, the catheters were out of the map.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 sedation protocol was modified, the issue did not recur.In addition, the issue was investigated by device manufacturer.Conclusion: ¿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 shift of the heart position in the carto z axis, hence leading to 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 preventative maintenance of the carto has been correctly performed and all the related tests 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: 5723912
• MDR Text Key: 48414832
• Report Number: 3008203003-2016-00023
• 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: 04/27/2016

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: 04/22/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• 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