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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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
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).
 
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.
 
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Brand NameCARTO 3 RMT SYSTEM
Type of DeviceCOMPUTER, 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 Key6967139
MDR Text Key248325319
Report Number2029046-2017-01032
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K090017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFG560000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
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

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