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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 Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2016
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 during an atrial fibrillation - persistent procedure there was a map shift. The system never asked to perform the learn new action. No error message was provided by the system. The lasso and the smart touch sf catheters were between 3 and 5mm outside the created fast anatomical map (fam). No cardioversion was performed. The patient did not move during the procedure. The procedure was completed with no patient consequence. Since there was no error provided by the system, no cardioversion was performed and the patient did not move during the procedure, this event has been assessed as reportable. The awareness date is may 24, 2016.
 
Manufacturer Narrative
(b)(4). It was reported that during an atrial fibrillation ¿ persistent procedure there was a map shift. The system never asked to perform the learn new action. No error message was provided by the system. The lasso and the smart touch sf catheters were between 3 and 5mm outside the created fast anatomical map (fam). No cardioversion was performed. The patient did not move during the procedure. The procedure was completed with no patient consequence. The root cause of the issue was determined to be the sedation of the patient that was causing a diaphragm movement and then a chest relaxation that cannot be compensated by carto and causes a sure map shift. After the sedation protocol was modified, the issue did not recur. In addition, the issue was investigated by the device manufacturer. Conclusions: ¿the carto system was performing as expected (no product malfunction). During the case after creation of a map, some sedative drugs were given to the patient which could have caused diaphragmatic relaxation. This may cause a shift of the heart position in the carto z axis, hence leading to an unidentified map shift. This was confirmed with the physician and once a change in the workflow was introduced (giving sedation before initial map is created/ other drugs) this did not recur¿. The system was tested after a supported case by the biosense webster field service engineer, with all the acceptance testing procedures passed. System is operational. The device history record (dhr) 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 Key5721888
MDR Text Key48421674
Report Number3008203003-2016-00021
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeIT
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 05/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2016
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 Received05/24/2016
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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