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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Catalog Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2019
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. Manufacture reference no: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with the carto® 3 system and a map shift error occurred. At the beginning of the procedure the patient interface unit (piu) displayed contact force sensor error 106. The cable was changed from the piu, but the problem persisted. Replacement of the unk_smart touch bidirectional sf catheter resolved the issue. During ablation, after drug administration, the map shifted about 1. 5 cm. Software version 6 was in use. The observed contact force sensor error 106 has been assessed as not mdr reportable. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote. The observed map shift has been assessed as an mdr reportable malfunction as map shifted with no error message, patient movement, or cardioversion.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key9142702
MDR Text Key164241004
Report Number2029046-2019-03708
Device Sequence Number1
Product Code DQK
UDI-Device Identifier10846835000870
UDI-Public10846835000870
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 09/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received09/06/2019
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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