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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 08/30/2018
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.(b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system and during the procedure a map shift of 1-1.5 cm with no error message issue occurred.There were no errors or spikes in metal values.There was no patient movement or cardioversion prior to the map shift.It was noted that there was no fluoroscopy tube around the patient during the procedure.Physician was able to work around the issue and proceeded with the case.There were no patient consequences.The issue of map shift no error message has been assessed as reportable.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system and during the procedure a map shift of 1-1.5 cm with no error message issue occurred.There were no errors or spikes in metal values.There was no patient movement or cardioversion prior to the map shift.The map shift/no error message, no patient movement/no cardioversion was assessed as mdr reportable.Information was received on 9/25/2018 on the event.The map shift was noticed during the ablation phase of the study.On 10/9/2018, the manufacture date of: 2/25/2015 was provided.Since the manufacture date was received, populated device manufacturer date.Information was received on 10/10/2018 from the biosense webster inc.(bwi) field service engineer indicating that the previously reported map shift, no error message issue was caused by patient movement after defibrillation.Clarification was requested and received on 10/16/2018 from a bwi representative confirming that the physician determined that there was 1 cardioversion prior to the map shift.Per additional information received, this event is no longer considered mdr reportable.However, since it has already been reported to fda, any additional updates received will continue to be reported.The investigational analysis has been completed.The bwi fse spoke to the bwi representative and was informed that the map shift issue happened after cardioversion and that the issue was related to patient movement.The system is in service and ready to use.Per the carto 3 instructions for use, when the relative position between the patches remains the same, but the position of the heart relative to the back patches has changed (ex: after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted) the system will not give a warning and an incorrect map (map shift) might be generated.A device history record (dhr) review was performed by the manufacturer.No anomalies related to the reported issue were noted in manufacturing or servicing of this equipment.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 Key7910265
MDR Text Key122163689
Report Number2029046-2018-02114
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 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Initial Date Manufacturer Received 08/30/2018
Initial Date FDA Received09/26/2018
Supplement Dates Manufacturer Received09/25/2018
Supplement Dates FDA Received10/24/2018
Patient Sequence Number1
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