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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999

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BIOSENSE WEBSTER INC. CARTO 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 Back to Search Results
Catalog Number FG540000J
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
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. Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(6). (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a carto® 3 system and a procedure delay (high risk) occurred. It was reported that during ablation procedure using the carto® 3 system when booting up the workstation and the patient interface unit (piu), the carto® 3 system showed error 1006 ¿back patch sensor error¿. General anesthesia got delayed until the issue could be resolved. Replacing the back patch cables didn¿t resolve the issue. Switching back to the initial back patch cable and restarting both the workstation and the piu with any metal removed from the vicinity of the location pad resolved the issue at first, so the patient was put under general anesthesia. However, the error reoccurred when getting access. When restarting both the piu and workstation again, the process of establishing communication between the piu and workstation (error 1 to error 2 to error 3), restarted after reaching error 3. The location pad cable was tied to the location pad to prevent any strain on the pig tail, all cables were removed from the piu and both the piu and the workstation were shut down and rebooted. After the reboot all patches were showing within the accuracy zone of the location setup. However, patch 3 was showing metal values around 70. Switching over to the spare back patch cable resolved the issue and the procedure could be completed successfully after a delay of approximately one hour. The customer¿s reported location patch issues are not mdr reportable since the issue is highly detectable and the most likely harm is a procedure delay or cancellation. The reportable event is the procedural delay which is considered to be high risk to patient.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceSIMILAR DEVICE FG540000, 510K # K042999
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 Key9509205
MDR Text Key200055152
Report Number2029046-2019-04056
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeAS
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 12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFG540000J
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 Received02/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2011
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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