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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-5830-01
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2016
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 a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto 3 rmt system. During mapping, a map shift occurred with no error message while using a pentaray catheter and a navistar catheter. It was noted as the catheter was outside of the previous map. The difference in catheter location before and after the map shift was approximately 30mm as it was measured afterwards with a distance tool. The patient did not move before detecting the shift. The physician did not perform a cardioversion prior to the map shift. The procedure was completed with an rmt catheter. There was no patient consequence. Since there was no error message and there was no patient movement or cardioversion prior to the map shift, this event is assessed as a reportable malfunction. Such map shifts could potentially be caused by a system malfunction and could be a potential risk to the patient.
 
Manufacturer Narrative
Manufacturer's ref. No: (b)(4). It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto 3 rmt system. During mapping, a map shift occurred with no error message while using a pentaray catheter and a navistar catheter. It was noted as the catheter was outside of the previous map. The difference in catheter location before and after the map shift was approximately 30mm as it was measured afterwards with a distance tool. The patient did not move before detecting the shift. The physician did not perform a cardioversion prior to the map shift. The procedure was completed with an rmt catheter. There was no patient consequence. The biosense webster field service engineer reported that they used the following workflow: they started the procedure with magnets in working position with an rmt navigational catheter. Then they moved the magnets to home position and used a pentaray catheter and navistar catheter. Finally, the rmt navigational catheter was connected again and the magnet moved to the working position. At this time, the customer had a map shift. The issue was not reproduced for manual and rmt cases again. Afterwards, if a manual case was performed or an rmt case using an rmt navigational catheter, there was no problem. Issue was related to the workflow used for that specific case. Conclusion was provided to the customer along with recommended workflow stated in v4 instructions for use (ifu). System is working according to specifications. The issue was investigated by the device manufacturer r&d department (investigation#(b)(4)), and the biosense webster field service engineer conclusion was confirmed. Such behavior is caused by moving rmt magnets in and out. In most cases, the upper torso is pushed by the magnets while the patient's back moves very little. In such case, the heart moves, but the patient¿s back remained almost with no movement. The carto 3 system cannot detect/compensate such movements. According to the carto 3 system instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed, the system will not give a warning and an incorrect map (map shift) might be generated. 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 RMT 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 Key6077644
MDR Text Key59560621
Report Number3008203003-2016-00037
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K090017
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 10/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM-5830-01
Device Catalogue NumberFG560000
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 Received10/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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