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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 Improper Device Output (2953)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
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.Still pending is the manufactured date.Therefore, a supplemental report will be submitted to update the manufactured date.(b)(4).
 
Event Description
It was reported a patient underwent a pvi procedure with a carto 3 system and a map shift occurred during the procedure.No patient consequences were reported.It was reported that during a pvi procedure, while doing the fam and after ablation, a sever map shift appeared.There was no location movement or warning message displayed on carto.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
 
Manufacturer Narrative
On 05/01/2018, the manufactured date was received.Therefore, device manufacture date has been populated with 5/19/2014.Manufacturer's ref.No: (b)(4).
 
Manufacturer Narrative
It was reported a patient underwent a pvi procedure with a carto 3 system and a map shift occurred during the procedure.No patient consequences were reported.It was reported that during a pvi procedure, while doing the fam and after ablation, a sever map shift appeared.There was no location movement or warning message displayed on carto.Product evaluation details: the field service engineer (fse) confirmed the issue was related to user error.The customer did not adjust the system according to source-image distance (sid) values.Fse referred the clinical staff to tolerate the sid values.It was confirmed that during following procedure, no map shift occurs.System is operational.Dhr review was performed by the manufacturer and no anomalies 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 Key7473707
MDR Text Key106979098
Report Number2029046-2018-01493
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,foreig
Type of Report Initial,Followup,Followup
Report Date 04/11/2018
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? No
Initial Date Manufacturer Received 04/11/2018
Initial Date FDA Received04/30/2018
Supplement Dates Manufacturer Received05/01/2018
06/03/2018
Supplement Dates FDA Received05/08/2018
06/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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