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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 Pacing Problem (1439)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
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. 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 (vt) ablation procedure with a carto® 3 system and unwanted pacing device malfunction occurred. It was described that during the procedure, there was an issue with double pacing. When the customer chose a routed channel, the system delivered pacing from that channel and also delivered pacing from ref/deca 7-8 port. Replacing the workstation did not resolve the issue. There was no patient consequence reported. The unwanted pacing issue was assessed as a 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, CA 92618
949789-868
MDR Report Key9492290
MDR Text Key199723727
Report Number2029046-2019-04024
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
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 Received02/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2010
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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