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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 06/26/2018
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.Concomitant products: ez steer¿ nav bi-directional electrophysiology catheter (catalog # bn7tcdf4l, lot # 30031233m) and smartablate generator (catalog # unknown, serial # unknown).(b)(4).
 
Event Description
It was reported that a patient underwent an atrioventricular node ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and a carto 3 system wherein the catheter experienced a char issue and the carto 3 system encountered a map shift issue without error messages.There were no patient consequences as a result of these events.During the procedure, a small right-to-left axis map shift was discovered when the catheters on the septum appeared mid-chamber.Approximate difference in catheter location before and after the map shift was 5mm.No error messages were observed.There was no patient movement.System was rebooted and the issue resolved.Procedure was successfully completed, however, this issue is considered an mdr reportable malfunction.During ablation, the ez steer navigational catheter delivered low wattage.Ez steer catheter was removed from the patient.Upon visual inspection, char was observed on the catheter tip.Ez steer catheter was exchanged for an 8mm catheter (unspecified) and the issue resolved.Procedure was completed without patient consequences.There have been no reports of neurological signs or symptoms since the procedure was completed.This issue is not mdr reportable.Generator was set on temperature control mode with standard parameters, per ifu.Although the power was set at 35 watts, the only 12-16 watts was being delivered.There were no issues related to temperature or flow, as this was not an irrigation catheter.No anticoagulants were used during the procedure.
 
Manufacturer Narrative
It was reported that a patient underwent an atrioventricular node ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and a carto 3 system wherein the catheter experienced a char issue and the carto 3 system encountered a map shift issue without error messages.There were no patient consequences as a result of these events.Product evaluation details: the bwi field service engineer spoke with the bwi field representative.The bwi field representative reported that rebooting the carto 3 system resolved issue.System is ready for use and no other similar complaints have been reported.Issue has not been duplicated.Dhr review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer¿s ref # (b)(4).
 
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Brand Name
CARTO 3 SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key7714891
MDR Text Key114953151
Report Number2029046-2018-01841
Device Sequence Number1
Product Code DQK
UDI-Device Identifier10846835000870
UDI-Public10846835000870
Combination Product (y/n)N
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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