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

Model Number M-5830-01

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

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 a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto 3 rmt system.During mapping, a map shift occurred with no error message while using a pentaray catheter and a navistar catheter.It was noted as the catheter was outside of the previous map.The difference in catheter location before and after the map shift was approximately 30mm as it was measured afterwards with a distance tool.The patient did not move before detecting the shift.The physician did not perform a cardioversion prior to the map shift.The procedure was completed with an rmt catheter.There was no patient consequence.Since there was no error message and there was no patient movement or cardioversion prior to the map shift, this event is assessed as a reportable malfunction.Such map shifts could potentially be caused by a system malfunction and could be a potential risk to the patient.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto 3 rmt system.During mapping, a map shift occurred with no error message while using a pentaray catheter and a navistar catheter.It was noted as the catheter was outside of the previous map.The difference in catheter location before and after the map shift was approximately 30mm as it was measured afterwards with a distance tool.The patient did not move before detecting the shift.The physician did not perform a cardioversion prior to the map shift.The procedure was completed with an rmt catheter.There was no patient consequence.The biosense webster field service engineer reported that they used the following workflow: they started the procedure with magnets in working position with an rmt navigational catheter.Then they moved the magnets to home position and used a pentaray catheter and navistar catheter.Finally, the rmt navigational catheter was connected again and the magnet moved to the working position.At this time, the customer had a map shift.The issue was not reproduced for manual and rmt cases again.Afterwards, if a manual case was performed or an rmt case using an rmt navigational catheter, there was no problem.Issue was related to the workflow used for that specific case.Conclusion was provided to the customer along with recommended workflow stated in v4 instructions for use (ifu).System is working according to specifications.The issue was investigated by the device manufacturer r&d department (investigation#(b)(4)), and the biosense webster field service engineer conclusion was confirmed.Such behavior is caused by moving rmt magnets in and out.In most cases, the upper torso is pushed by the magnets while the patient's back moves very little.In such case, the heart moves, but the patient¿s back remained almost with no movement.The carto 3 system cannot detect/compensate such movements.According to the carto 3 system instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed, the system will not give a warning and an incorrect map (map shift) might be generated.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 RMT 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: 6077644
• MDR Text Key: 59560621
• Report Number: 3008203003-2016-00037
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090017
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1