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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2019
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. Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(6). (b)(4).
 
Event Description
It was reported that male patient underwent a left atrial flutter ablation procedure with a carto® 3 system and a ¿current leakage¿ error was displayed during use. Actions taken included first catheter kit (materials) replacements and the carto® 3 system worked fine for a while but afterwards the problem persisted. The carto® 3 system has been reset a few times, but nothing happened. Therefore, the caller did not know if the problem was material or the carto® 3 system. To preserve patient safety, the physician was encouraged to discontinue the procedure as the patient had been under general anesthesia for 3 hours. Patient reportedly fully recovered with no residual effects and there was no other patient consequence. The patient was to be rescheduled to do another ablation procedure. The ¿current leakage error¿ was not displayed due to a noise issue. Transseptal puncture had been performed prior to the procedure cancellation. In the opinion of the physician, this certainly presented risk of injury because the doctor was not able to finalize the ablation. The procedure was canceled in middle due to this issue. The physician chose to stop the mapping and ablation was not performed. The patient had no treatment for his arrhythmia and will have to come back to the hospital to do another procedure. No extended hospitalization was required. The cause of the event was bwi product malfunction. Since it was stated by the caller that the catheters/materials were replaced without resolution, it¿s been determined that the error was caused by a problem with carto® 3 system itself, therefore, the procedure cancellation issue will be conservatively reported under the carto® 3 system.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key9497692
MDR Text Key199724164
Report Number2029046-2019-04025
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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