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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 Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: the investigational analysis has been completed. The biosense webster, inc. Field service engineer arrived on site for troubleshooting and repair. The system was started up, ecg tests (amplitude, limb, noise and pacing) and acl (raw current) were carried out, which ended satisfactorily and within the parameters specified by the manufacturer. The field service engineer tried to replicate the issue, simulating the configuration of equipment used during the procedure and no interference was observed in the generated ecg signal. The issue was not duplicated. System is operational. 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's reference (b)(4).
 
Event Description
It was reported that a patient underwent an unknown procedure using the carto® 3 system and it was clarified that there was no ecg signal available to monitor the patient¿s heart rhythm. Initially, it was reported that when placing the radio frequency (rf) catheter, the readings were unstable, and noise was generated on the ecg. There was no patient consequence. With the information available, this event was assessed as not reportable as it was not reported that there were no ecg signals available to monitor the patient¿s heart rhythm. Therefore, the most likely consequence was an intraprocedural delay. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote. Additional information was received on (b)(6) 2019 stating that the noise was observed on both the intracardiac electrogram (ic) and body surface (bs) signals. The noise spread to both the carto and the recording system. The noise also appeared on the anesthesia monitor, leaving the physician with no available ecg signal. This event was originally considered non-reportable, however, biosense webster, inc. Became aware that there was no ecg signal available to monitor the patient¿s heart rhythm on (b)(4) 2019 and per this additional information have reassessed the event as reportable. Therefore, the awareness date is reset to (b)(4) 2019.
 
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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
33 technology drive
irvine, CA 92618
949789-868
MDR Report Key8340473
MDR Text Key139226813
Report Number2029046-2019-02686
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeAR
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
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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