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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 FG560000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2019
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 ref # (b)(4).
 
Event Description
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred. It was initially reported that after ablations had been completed, they went back to create a voltage map and when the re-map was created there was an obvious shift in the re-map. No warnings, alerts, or errors seen on the carto 3 system. No fluoro was in use. The procedure continued with the re-map. There was no patient consequence. The reported map shift issue was initially considered not mdr reportable since there was no information indicating if there was cardioversion or patient movement. On 6/3/2019, biosense webster inc. Received additional information about the event indicating that the approximate difference in catheter location before and after map shift was 1 cm approximate, caudal and anterior. No patient movement detected; patient was under general anesthesia and no cardio-version was performed. It was additionally reported that all the metal values were <2, with a possibility that someone actually moved x-ray c-arm away from field if anything. Thereby reducing metal values. This event was originally considered non-reportable, however, based on the information received on 6/3/2019, the event has been reassessed as mdr reportable as a malfunction since the information indicated the physician did not perform cardioversion, there was no patient movement and there was no error messages given by the system.
 
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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 Key8732438
MDR Text Key150165931
Report Number2029046-2019-03322
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090017
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 05/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFG560000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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