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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-4800-01
Device Problems Flushing Problem (1252); Issue With Displayed Error Message (2967); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2016
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. (b)(4).
 
Event Description
It was reported that a patient underwent a right atrial flutter procedure with a carto® 3 system and a map shift without error message occurred. During mapping, there were high temperatures of 43°c being displayed by the catheter. The temperature cutoff was 43°c and the generator stopped ablation when the cutoff was reached. The catheter was removed from the body and it was then noticed that it was not flushing properly. The catheter was replaced and the issue resolved. When the replacement catheter was inserted into the body, it was noticed that the catheter appeared outside the map shell and therefore a map shift had occurred. There was a significant difference in the catheter location before and after the map shift. The new location was higher on the screen than the old one. There were no metal errors or warnings displayed. A new map was created; the procedure was continued and subsequently completed with no patient consequence. This event is mdr reportable because map shifts with no error message could potentially cause a potential risk to the patient. The high temperature and irrigation issue 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.
 
Manufacturer Narrative
(b)(4). It was reported that a patient underwent a right atrial flutter procedure with a carto® 3 system and a map shift without error message occurred. When the replacement catheter was inserted into the body, it was noticed that the catheter appeared outside the map shell and therefore a map shift had occurred. The field service engineer (fse) followed up on the issue with a bwi representative and asked for more information on case details during time of the map shift. Fse supplied bwi representative with patch placement guidelines and actions to take and check when a map shift occurs and referenced "advanced training ". Bwi representative informed fse that following guidelines for map shifts the issue was not duplicated and following cases completed successfully. The system is operational. Device manufacturer requested study data for review; however the study data could not be analyzed because the study data was not available to send for investigation. The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
 
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Brand NameCARTO® 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key5548253
MDR Text Key42890390
Report Number3008203003-2016-00011
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM-4800-01
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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