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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
Catalog Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
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. Manufacture reference no: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a carto® 3 system, and a map shift issue occurred. During ablation procedure, the physician noticed a map shift without any error message on carto 3 system. According to the initial fast anatomical map (fam), the 20 poles on the pentaray nav high-density mapping catheter were not in an accurate position when in the veins. Extended features were turned on and patch placement was looked at. Initially it was reported, that one of the back patches moved by 4. 3mm approximately according to the values and the other 2 back patches where in exact same position. Clarification was received indicating that upon examination, one of the back patches had moved about 0. 5cm relative to the other. The physician asked for fam of the veins again, to make sure he was in a good position to burn. No error message was displayed and the map was recreated with a minor 4 minute procedure delay. No patient consequence was reported. There was no patient movement or cardioversion. The issue of a map shift without patient movement, cardioversion or error messages is considered mdr reportable.
 
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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 Key8799076
MDR Text Key152064785
Report Number2029046-2019-03428
Device Sequence Number1
Product Code DQK
UDI-Device Identifier10846835000870
UDI-Public10846835000870
Combination Product (y/n)N
Reporter Country CodeCA
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 06/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/20/2019
Was Device Evaluated by Manufacturer? Yes
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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