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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 EP NAVIGATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER INC. CARTO 3 EP NAVIGATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 10439011
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/10/2016
Event Type  malfunction  
Event Description
Poor signal during procedure. When the catheter was connected, the image on the display was poor. The catheter was removed, and a new catheter was used. The new catheter worked fine with clear image. No injury to the patient.
 
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Brand NameCARTO 3 EP NAVIGATION SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
15715 arrow hwy
irwindale, CA 91706
MDR Report Key5837126
MDR Text Key50883189
Report Number5837126
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10439011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/20/2016
Event Location Other
Date Report to Manufacturer07/20/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
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