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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 Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem Discomfort (2330)
Event Date 09/23/2016
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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. A map shift of approximately 5cm occurred during mapping and no error message populated. The map shift was discovered because of the inconsistency between the fast anatomical map and contact force. There was no patient movement and no cardioversion was performed. The physician had to remap the chamber to continue the procedure. There was an hour and half delay. According to the physician the delay issue could not cause or contribute to any serious injury of the patient. Only discomfort was reported. The procedure was completed with no patient consequence. Additional information has been requested. However, no further information has been made available. The procedure delay was assessed as not reportable as there was no risk to the patient's health status indicated. The patient's discomfort has been assessed as non serious and therefore not reportable as there is no evidence of medical/surgical intervention or prolonged hospitalization. The map shift with no error message has been assessed as a reportable malfunction as such map shifts could potentially be caused by a system malfunction and there is a potential risk to the patient.
 
Manufacturer Narrative
Additional information was received on this event on (b)(6) 2016. It was reported that the patient was a (b)(6) year male. Patient's weight was 90 kg. The patient¿s diagnosis pre-procedure was ventricular tachychardia. The physician¿s opinion on the cause of the patient¿s reported discomfort was the patient¿s condition. This issue did not require medical or surgical intervention. The patient did not require extended hospitalization. The patient fully recovered. Manufacturer's ref. No: (b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. A map shift of approximately 5cm occurred during mapping and no error message populated. The map shift was discovered because of the inconsistency between the fast anatomical map and contact force. There was no patient movement and no cardioversion was performed. The physician remapped the chamber to continue the procedure. There was an hour and half delay. According to the physician the delay issue could not cause or contribute to any serious injury of the patient. Only discomfort was reported. The procedure was completed with no patient consequence. The full system testing was performed for confidence and preventive maintenance. All carto 3 acceptances testing procedure passed. The biosense webster field service representative confirmed that the carto 3 was operational. It was discovered that the map shift issue was not caused by the carto system. Physicians are instructed on the occurrences that can lead to map shift and that are not notified by the system. The biosense webster field service representative confirmed that the issue was not duplicated in the following system usages. 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 Key6041678
MDR Text Key57981020
Report Number3008203003-2016-00034
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 09/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2016
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 Received09/23/2016
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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