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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 05/15/2019
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. Manufacturer's reference # (b)(4).
 
Event Description
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a carto® 3 system and it was described that there was a map shift with no error message or no patient movement/cardioversion. Initially, it was reported that when they introduced the. 035 guide wire that comes with the sl1 sheath, there was a noticeable shift in catheter position on all catheters. There were no error codes that were displayed, and the metal values were within specifications. The catheters would return to their normal/correct positions when the guide wire was removed. The issue was reproducible. There was no patient consequence reported. On may 17, 2019, additional information was provided, and it was noted that the issue was seen during mapping, during the advancement of the wire to go transseptal. The approximate difference in catheter location before and after map shift was approximately 10 mm. It was also noted that there was no cardioversion performed, as the patient was under general anesthesia, therefore there was no movement. The issue of map shift with no error message or no patient movement/cardioversion was assessed as a reportable event.
 
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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 Key8668054
MDR Text Key150162459
Report Number2029046-2019-03207
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
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 Received07/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2016
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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