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

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Low impedance (2285); Device Displays Incorrect Message (2591)

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

Event Date 08/17/2015

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 continuation: the generator also detected low impedance.It was lower than the allowed impedance for the generator to start the ablation.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This issue was also assessed as not reportable.Since the artifact was displayed on all channels, there was no signal available to monitor patient's cardiac rhythm and the lack of monitoring of the cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.Therefore, this issue has been assessed as a reportable malfunction.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and there was a large amount of artifact on all channels.During ablation, a large amount of artifact was displayed on all channels on both the recording system and the carto 3 system.All signals were affected and the physician did not have any signals available to monitor the patient's heart rhythm.A current leakage error pop up box was displayed and no error code was associated to it.The pop up message stated to turn off the patient interface unit (piu) immediately.The patient interface unit (piu) was rebooted, the ablation cable was replaced and the issue remained.They noticed that the connection from the grounding pad to the adapter cable to the stockert 70 was sitting on the patient warmer and was very hot.The ecg artifact improved and went away gradually after the connection was removed from the patient warmer.As the ecg noise went away, they were able to pace.Also no temperature was displayed and the stockert generator indicated that the impedance was "lo".The ablation would not come on.The ablation catheter was replaced and the issue remained.They were not able to ablate again but the procedure was already completed successfully.However, the physician was not able to confidently assess procedural completion to his satisfaction due to the inability to pace, ablate or view pacing conduction.Since there is no temperature displayed, ablation cannot be initiated.Therefore, the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This issue was assessed as not reportable.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).During ablation, a large amount of artifact was displayed on all channels on both the recording system and the carto 3 system.A current leakage error pop up box was displayed and no error code was associated to it.The pop up message stated to turn off the patient interface unit (piu) immediately.The patient interface unit (piu) was rebooted, the ablation cable was replaced and the issue remained.They noticed that the connection from the grounding pad to the adapter cable to the stockert 70 was sitting on the patient warmer and was very hot.The ecg artifact improved and went away gradually after the connection was removed from the patient warmer.As the ecg noise went away, they were able to pace.Also no temperature was displayed and the stockert generator indicated that the impedance was "lo".The ablation would not come on.The ablation catheter was replaced and the issue remained.They were not able to ablate again but the procedure was already completed successfully.This was a user error issue.When the grounding pad was separated from the warmer ,the issue resolved.The bwi field service engineer contacted the bwi field representative and was informed that the procedure was completed without any issues.The issue was not duplicated.The system is ready for use.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: 5076218
• MDR Text Key: 26238639
• Report Number: 3008203003-2015-00074
• 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
• Reporter Occupation: Other
• Report Date: 08/17/2015

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: Not provided
• Initial Date FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1