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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC. CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number FG540000
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2019
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. Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(4).
 
Event Description
It was reported that a patient underwent a ventricular tachycardia ablation procedure using the carto® 3 system and a noise on all ecg signals occurred. It was reported that during the ventricular tachycardia ablation procedure the carto® 3 system which restarted by itself. It shut down and reopened again. Later, ¿error 7¿ appeared ("current leakage"). Next, there was noise on unipolar signal with the smartablate on and noise on ecg body surface and on all ecgs during application. The case was completed with delay of around 30 minutes. There were no patient consequences. On 11/29/2019, additional information was received confirming the noise appeared on the bs ecg on both the carto® 3 system and recording system. During the event the physician did not have any ecg signals to monitor the patient's heart rate. In physician¿s opinion, the delay did not contribute to a death or serious injury to the patient. The customer¿s reported system (software) crash, the current leakage error and the procedure delay are to be considered non-mdr reportable since the potential risk that any of these could cause or contribute to a death or serious deterioration in state of health is remote. However, on 11/29/2019 bwi became aware of additional information indicating the physician had no other way of monitoring the patient¿s heart rate and reassessed the issue of noise on all ecgs to be an mdr reportable malfunction.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine 92618
949789-868
MDR Report Key9501158
MDR Text Key200011155
Report Number2029046-2019-04045
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
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 Received11/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2009
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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