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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 10/07/2020
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 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 an atrial fibrillation (afib) cardiac ablation procedure with a carto 3 system where a map shift with no error message, no patient movement and no cardioversion issue occurred. Initially, it was reported that during the procedure, when going to the left side of the heart to begin ablation, after creating fast anatomical mapping (fam) for the left atrium, it was noticed that the visitags were not lining up with the fam. The visitags were completely outside of the fam zone. No error messages or alerts were displayed on the carto 3 system, and no fluoroscopy system was in use. At the same time, when heading towards the right side of the heart, the pentaray catheter splines had disappeared, and reappeared shortly after. A new map was created, and the issue had resolved. The procedure continued. There was no report of patient consequence. Multiple attempts had been made to obtain clarification to this complaint. With the information available, the event was assessed as a visitag issue and a map shift issue. The visitag issue was assessed as not mdr reportable. The visitag provides supplemental information to aid in ablation procedures. If visitags points are lost, inaccurate, or unable to be obtained, then this would be highly detectable. The acquisition of visitag points is not necessary to perform ablation procedures. Points can be taken manually, and ecg rhythm is the ultimate guiding feature of ablation procedures. An issue with visitags does not affect patient risk. The map shift issue reported does not indicate that there was no patient movement and no cardioversion performed. Therefore, this map shift event was assessed as not mdr reportable. Additional information was received on 10/16/2020. There was no problem with visitags. No information was lost. No inadvertent ablation was performed. System did not provide any error. Map shift was discovered when visitags were well outside the fast anatomical mapping shell. Issue was seen during the ablation. The difference was approximately 8mm. No cardioversion was performed and patient never moved. To complete the procedure, the left atrium was remapped with the pentaray catheter and continued with pulmonary vein isolation (pvi). Per the additional information received stating that this was a map shift issue with no error message, no patient movement and no cardioversion, this complaint was reassessed to a mdr reportable malfunction and the awareness date is 10/16/2020. The catheter visualization issue was assessed as not mdr reportable. 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.
 
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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 Key10840448
MDR Text Key216413099
Report Number2029046-2020-01722
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2011
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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