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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 No Display/Image (1183); Issue With Displayed Error Message (2967); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2017
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 sided atrial flutter procedure with a carto® 3 system and a map shift without error message occurred. Error 8 ¿stimulation routing is disabled¿ displayed on the carto® 3 system. The pacing leads were connected to the carto® 3 patient interface unit (piu) primary pacing port. A bloom stimulator was used during the procedure. The pacing was for planned pacing and no pacing was delivered. Everything was blacked out on the carto® 3 including no mapping or fast anatomical mapping available. All catheters and cables were removed and the piu was rebooted. The error was resolved after reboot and after reconnecting all catheters, the error did not return and the case continued. Then, while mapping, there was a map shift with no error message or patient movement. The map shift was confirmed by the physician using fluoroscopy and looking at the map created with carto® 3. The measured map shift distance was 16. 9mm; the carto was used to measure the difference. There was no prior cardioversion and the patient was fully sedated prior to procedure. The pacing error is not mdr reportable because the potential that this issue could cause or contribute to a death or serious deterioration in the patient¿s state of health is remote. The map shift is mdr reportable because map shifts could potentially be caused by system malfunction, and there is a potential risk to patient.
 
Manufacturer Narrative
(b)(4). It was reported that a patient underwent a right sided atrial flutter procedure with a carto® 3 system and a map shift without error message occurred and error 8 ¿stimulation routing is disabled¿ displayed on the carto® 3 system. Error 8 was resolved by removing all catheters from patient interface unit (piu) and performing a piu reboot. When connecting all catheters the error did not return and the case was completed. The field service engineer (fse) cannot determine the cause of the error. The error has not returned. It was also reported that while mapping there was a map shift and there was no patient movement. It was clarified by the bwi representative that the issue was seen after re-initializing and restarting the piu after they had the error 8. Fse reported that the map shift was not reproduced in following case. 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 Key6361267
MDR Text Key68969001
Report Number3008203003-2017-00010
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
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 02/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2017
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 Received02/02/2017
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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