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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 a cavotricuspid isthmus (cti) ablation procedure for right atrial flutter with a carto® 3 system and a map shift ¿ no error occurred.After right atrial flutter termination, a map shift was noted on the carto® 3 system.The approximate difference in catheter location before and after the map shift was 2 cm.Chest patches were 1.3 cm above the original location on the z-axis.There were no errors or warnings indicating patient movement or a map shift.There was no patient movement or cardioversion prior to the map shift.There were no patient consequences.The map shift ¿ no error issue has been assessed as reportable.
 
Manufacturer Narrative
It was reported that a patient underwent a cavotricuspid isthmus (cti) ablation procedure for right atrial flutter with a carto® 3 system and a map shift ¿ no error occurred.After right atrial flutter termination, a map shift was noted on the carto® 3 system.On (b)(6) 2018, information was received indicating the manufacture date of (b)(6) 2017 for carto 3 system serial # 34421.Corresponding fields of this report have been updated.The investigational analysis completed on (b)(6) 2018.Attempted follow ups were performed to obtain a purchase order for service with no success.The field service engineer confirmed that the preventative maintenance request is no longer needed.Service was declined.The biosense webster inc.Representative trained and advised to renew catheter visualization or learn new when patient movement causes map shifts.No issue reoccurred.System was ready for use.The device history record (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 ref 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 92618
MDR Report Key7920337
MDR Text Key122638493
Report Number2029046-2018-02124
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
Date FDA Received09/28/2018
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 Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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