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

Model Number M-4800-01

Device Problems Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Impedance Problem (2950); Unintended Movement (3026)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system, and a mapshift with no error message issue occurred.It was a left sided afib procedure.There was a spike in the impedance when coming on rf energy and the generator would not deliver energy several times in the region of the roof around the os of the left upper pulmonary vein.The lasso dongle cable and the rf generator dongle were changed; however, there was no difference.The impedance when not ablating was 190 ohms on the roof and around 165 ohms when near the floor of the chamber.Each catheter was disconnected from the patient interface unit (piu) and there was no change to the impedance.The indifferent patch and cable were swapped for another.This made no difference.The ablation power was set to 30w and the flow was set to 17ml/min.The temperature cut off was set to 48°.They tried the ablation in temperature control mode (not power control mode) and though impedance was high, there was no spike in the impedance and the energy was delivered successfully.The physician isolated the two left sided veins and right upper, but when coming on with rf energy, the ablation catheter on the carto 3 system would move 15 - 20mm posteriorly from the initial position despite there being no such movement on fluoro.This was seen several times.Given that the right lower was a small vein, it was felt that they would not try and isolate given issues with the navistar visualization on the carto 3 system.The physician wanted to.

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.Concomitant products: 1.Smart touch unidirectional catheter (quantity (b)(4)) model #: d-1336-02-s, lot #: 17063857m, lot #: 17049359m.2.Webster 10 pole catheter: model #: d-1086-586-s, lot #: 17075613m.3.Lasso nav variable eco catheter: model #: d-1343-01-s, lot #: 17076157l.4.Ep - shuttle rf generator system - 100w: model #: 39d-76x, serial #: (b)(4).Event description continuation: perform a tricuspid annulus line, therefore they went into the right atrium and set the generator to 40w and the flow rate to 30ml/min on the coolflow pump.When the physician came on with energy, the catheter image on the carto 3 system moved dramatically posterior far more than in the left atrium.Two applications of energy were tried.However, it had the same affect.The procedure was abandoned.There was no patient consequence.Upon request, additional information was provided on the event, stockert was initially in power control mode and then in temperature control mode.The cut-off values were not exceeded.The patient was under local anesthesia.The transseptal puncture was performed.The physician did not consider the cancellation of the procedure an acute risk to the patient but there is a potential for the patient to have a repeat procedure.There was no extended hospitalization.The system did not populate an error message for the mapshift.The navistar catheter moved posteriorly only during ablation.It was not a real movement as the catheter position was checked on fluoro.The impedance issue is not reportable as the rf power delivery was deactivated immediately and the cut-off values were not exceeded.The procedure cancelled issue is not reportable as per the physician¿s opinion that it did not cause a risk to the patient.The mapshift-no error message issue is indicative of a reportable event.Per the additional information received on (b)(6) 2014 stating that there was no error message for the mapshift, this issue is indicative of a reportable event.The awareness date will be reset to (b)(6) 2014 as this is the date that we received the information that no error message populated.

Manufacturer Narrative

(b)(4) it was reported that when ablating the impedance spiked and energy could not be delivered.When the stockert generator was connected to the system and used in manual ablation mode, the carto 3 system was detecting the ablation signal as a stimulation spike.The customer was advised of the workaround of using the generator in temperature control mode, or in manual mode by increasing the power slowly.Issue related to bug #(b)(4).Additional information was reported stating that when coming on with rf energy, the ablation catheter on the carto 3 system would move 15 - 20mm posteriorly from the initial position despite there being no such movement on fluoro.This was seen several times.Given that the right lower was a small vein, it was felt that they would not try and isolate given issues with the navistar visualization on the carto 3 system.The physician wanted to perform a tricuspid annulus line, therefore they went into the right atrium and set the generator to 40w and the flow rate to 30ml/min on the coolflow pump.When the physician came on with energy, the catheter image on the carto 3 system moved dramatically posterior far more than in the left atrium.Two applications of energy were tried.However, it had the same affect.The procedure was abandoned.This issue was not reproduced in the next cases.In addition, the complaints after this event associated with this specific system were reviewed as well and there was no additional complaint related to the reported issue.A 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4242121
• MDR Text Key: 4992571
• Report Number: 3008203003-2014-00073
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• 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: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1