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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 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 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 procedure with a carto(r) 3 system and a map shift occurred with no error message, no patient movement and no cardioversion. It was reported that during procedure, external evaluation, there was a problem with inflation index. The value was not correct. They were able to see that it had a different value. They also mentioned a map shift. The procedure was completed with no patient consequence. Multiple attempts have been made to obtain clarification to this complaint. With the information available, the map shift was assessed as not mdr reportable as there was no information if there was an error message that populated, patient movement and cardioversion. The issue with the inflation index was assessed as not mdr reportable. The issue was highly detectable when occurring. The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low. Additional information was received on the event on 10/13/2020. No errors reported by the system. The map shift (approximately 5cm) was visually discovered by the physician during mapping. The map did not correspond to the one made initially. No cardioversion prior to catheter shift and no patient movement. The map shift with no error message, no patient movement and no cardioversion was reassessed as an mdr reportable malfunction. The awareness date for this reportable issue is 10/13/2020.
 
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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 Key10776368
MDR Text Key230695742
Report Number2029046-2020-01620
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
Report Date 10/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
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 Received12/21/2020
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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