MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 RMT SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG560000

Device Problems Signal Artifact/Noise (1036); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer site phone number (b)(4).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 a patient underwent a right sided atrial flutter procedure with a carto 3 rmt system and signal noise was observed.During the ablation of the tachycardia, approximately 3 deliveries into the procedure, the stockert rf generator displayed "hardware error 9".Based on previous recommendations and experiences, the generator was turned off and the power cycled.Upon the restart, it was noticed that signal noise had developed on the body surface channels and intracardiac signals of both the carto and the recording system (cardiolab by ge).Several attempts to troubleshoot the system were undertaken.The patient interface unit was restarted and the issue resolved.The case continued without further incident.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The hardware error is not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.However, if the patient's heart rhythm is not visible to the operator on all electrograms of body surface and intracardiac it could cause a potential risk to the patient.

Manufacturer Narrative

It was reported that a patient underwent a right sided atrial flutter procedure with a carto 3 rmt system and signal noise was observed.Restarting the patient interface unity, the signal noise issue resolved and the case continued without further incident.After the reboot, the noise issue cannot be duplicated.In addition, the complaints after this event associated with this specific system were reviewed as well and there were no additional complaints related to the reported issue.System is fully functional and ready for clinical use.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Management is notified of failure analysis through the monthly trending reports.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

This is a correction to the initial report.It was discovered on (b)(6) 2017, some incorrect information was provided in the initial report.Has been updated as incorrect information previously provided.Manufacturer's ref.No: (b)(4).

• Brand Name: CARTO 3 RMT SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 949789-383
• MDR Report Key: 6967139
• MDR Text Key: 90677630
• Report Number: 2029046-2017-01032
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/20/2017

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 Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 09/20/2017
• Supplement Dates FDA Received: 10/24/2017; 01/02/2018
• Was Device Evaluated by Manufacturer?: No
• 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