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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
Model Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2020
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.Manufacturer's ref #: (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and map shift issue occurred.It was reported that during the procedure, while mapping the right veins, the carto® 3 system had a significant map shift anterior and superiority.The metal values were low.A new map was started but the map shifted again more in line with the original map.The carto® 3 system did not display any error message.No pacemaker programmer or other type devices used.Patient did not move and there was no cardioversion that occurred prior to the map shift; the patient was strapped to the table.The movement was described as significant at approximately 2mm.There was no patient consequence reported.
 
Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and map shift issue occurred.It was reported that during the procedure, while mapping the right veins, the carto® 3 system had a significant map shift anterior and superiority.The metal values were low.A new map was started but the map shifted again more in line with the original map.The carto® 3 system did not display any error message.No pacemaker programmer or other type devices used.Patient did not move and there was no cardioversion that occurred prior to the map shift; the patient was strapped to the table.The movement was described as significant at approximately 2mm.There was no patient consequence reported.Device evaluation details: the device evaluation has been completed.The biosense webster inc.Field service engineer (fse) was informed by the bwi representative that rebooting the workstation and using a default template resolved the reported map shift issue.The case completed successfully, and the system is operational.The customer declined system testing.The device manufacturer requested the study data related to the reported issue for further evaluation, however, the bwi representative reported that the data was no longer available since it was previously deleted.As a result, the root cause of the reported map shift issue was not determined.The bwi representative confirmed that there have not been any issues since and the account continues to use the system.A manufacturing record evaluation was performed for the system 14637, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 Key9941816
MDR Text Key202100962
Report Number2029046-2020-00529
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
Source Type company representative
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFG540000
Device Catalogue NumberFG540000
Date Manufacturer Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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