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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 Alarm Not Visible (1022); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's ref. No: (b)(4). The investigational analysis has been completed. The biosense webster field service representative contacted the account regarding this issue. The biosense webster field service representative explained to the account all the possible cases in which a map shift can happen and the situations that carto can compensate or not. The biosense webster field service representative was informed by the account and physician that this map shift issue was not caused by the carto system and system was used many times after the occurrence, and no issue was reported. The system test was declined by customer. The biosense webster field service representative confirmed that the 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.
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. Just before starting the ablation phase, a map shift was noticed but the carto 3 system did not recognize it. The map shift was discovered as the catheter with more than 20gr of force was suddenly inside the map previously created. The approximate difference in catheter location before and after the map shift was more than 1cm. No cardioversion was performed prior to the map shift. The patient did not move before detecting the shift. The procedure was completed by guiding the ablation with the use of fluoroscopy with no patient consequence. Such map shifts without an error message could potentially be caused by a system malfunction and there would be a potential risk to the patient. Therefore, this event has been assessed as a reportable malfunction.
 
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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 Key6050730
MDR Text Key58556959
Report Number3008203003-2016-00035
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
Report Date 09/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2016
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?
Event Location No Information
Date Manufacturer Received09/26/2016
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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