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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 Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system where a map shift with no error message, no patient movement and no cardioversion issue occurred. It was initially reported that during the procedure, they had a map shift of the left atrium 2 times. They made another map after the first map shift; when had a second map shift, made a third map. No error on the screen and no alarm. It was also reported that they were using qdot, and the proximal electrode of the catheter appeared like a ring. Completed the procedure with no consequence. There was about a 30 minute delay. Attempts have been made to obtain clarification to this complaint. However, with the information available, the map shift, catheter visualization and procedure delay issues were assessed as not mdr reportable. Additional information was received on 9/22/2020. There was no error message observed. The map shift was discovered because the catheters were outside the fast anatomical mapping (fam) during mapping and during ablation. The difference was approximately 1 or 2 cm. No patient movement or cardioversion prior to the map shift. In physician¿s opinion the delay did not contribute to a death or a serious injury of the patient. The map shift with no error message, no patient movement and no cardioversion was assessed as a mdr reportable malfunction. The awareness date for this reportable issue is 9/22/2020. As there was no risk to the patient as a result of the procedure delay, both the procedure delay and the catheter visualization issues remain assessed as not mdr reportable.
 
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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 Key10702789
MDR Text Key228600709
Report Number2029046-2020-01507
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2009
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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