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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 Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
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 a persistent atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift with no error message, patient movement or cardioversion issue occurred. The pentaray catheter would not build matrix. The cable was replaced (not the 20 pole eco adapter) and the issue did not resolve. The catheter was replaced and the splines of the pentaray catheter would flicker in and out. The reporter seemed to think this was a bad custom template or a corrupt study. They exited the study then re-entered the same study stating that the new map was anatomically different than the original without patient movement. No further troubleshooting was completed. The case was completed at the time of the call. The system did not provide an error. Original map and final map were visually different. Lesions sets did not match original anatomy. The issue was seen during mapping and ablating for most of the case. The approximate difference in catheter location before and after map shift: original roof line was internal. Force requirements were set but the visit where obviously internal on the final map. The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift. The ¿catheter visualization¿ issue was assessed as not mdr reportable. The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote. The ¿unable to map¿ issue was assessed as not mdr reportable. Since the catheter cannot map by the carto 3 system, the user will not be able to use the device and will have to replace it. The most likely consequence was an intraprocedural delay. The potential risk that it could cause or contribute to a serious injury or death was remote. The ¿map shift with no error message, patient movement or cardioversion¿ was assessed as a mdr reportable malfunction.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam
IS
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key12278244
MDR Text Key265824025
Report Number2029046-2021-01277
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 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
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 Received09/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/05/2015
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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