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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 10/23/2019
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift occurred.Before ablation started, a 3mm map shift displayed on the carto 3 system.No error messages displayed and there was no cardioversion or patient movement.The catheter was stable as confirmed by fluoroscopy.No troubleshooting was performed.The grounding pad was well away from the green sensors.The sequence of events is not clear.However, this event will be conservatively reported since there was no cardioversion and no patient movement.No patient consequence was reported.The observed map shift issue has been assessed as an mdr reportable malfunction as there was no error message, cardioversion ,or patient movement.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift occurred.Before ablation started, a 3mm map shift displayed on the carto 3 system.No error messages displayed and there was no cardioversion or patient movement.The investigational analysis completed 12/30/2019.The field service engineer (fse) spoke to the biosense webster inc.(bwi) representative and was advised to change the patch unit or the patch sensor cable (green) to check if the issue would occur in the next case.Bwi representative confirmed that the issue did not occur after changing the patch unit with another patch unit from another site.Fse ordered a replacement patch unit.Thereafter, the fse confirmed that the site has received and installed it.The system was then returned to use.The suspicious patch unit was sent to quest repair center (refer to wo-389067).The center was requested to send the patch unit to carto 3 device manufacturer for investigation.The center informed that they have replaced already the original patch sensor cables (green and yellow ) with new ones and performed the required acceptance testing to the patch unit.The patch unit passed the testing, and it was installed in to another carto 3 # 14614 (refer to wo-394675).The original patch sensor cables (green and yellow) were disposed.Therefore, no investigation could be performed and as a result no root cause was identified.Manufacture record evaluation was performed by the manufacturer and no internal actions were noted in manufacturing or servicing of this equipment.The issue is related to an internal investigation.Manufacture reference no: (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 Key9341908
MDR Text Key195387845
Report Number2029046-2019-03885
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 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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