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Model Number FG540000
Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device problem code of ¿appropriate term/code not available" represents "delay procedure-high risk". 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 cardiac ablation procedure with a carto® 3 system where a procedure cancellation with high patient risk occurred. It was reported that the smartablate generator stopped ablating. There was an error saying impedance too high. They exchanged the ablation cable and the issue persisted. The catheter and the indifferent electrodes were exchanged and the issue persisted. They rebooted the generator and the issue persisted. The caller also exchanged the cable from the generator to the patient interface unit (piu) and the issue persisted. A css (rh) was called to further assist. The caller was advised to toggle back and forth the pacer indicator and the issue persisted. The pacing was closed on the carto® 3 system. The caller was advised if they saw any bent pins in the catheter and the piu; however, no damage was noted. The caller was then advised to reboot the piu and to disconnect and reconnect all cables and catheters into the piu. The caller confirmed the correct catheter was selected on the carto® 3 system. There was no error code being displayed. Only impedance was at maximum. After the reboot, the caller was then advised to exchange the ablation catheter and the issue persisted. The ablation catheter had the same lot number as the previous and they were advised to use a new catheter with a different lot number. The caller stated that all the catheters had the same lot number. They then opened a bi-directional catheter smart touch sf. They did not get an impedance reading. The caller was advised that the generator would then need to be exchanged. However, they did not have one available to exchange it with. The caller was advised to make sure the mapping catheter says none and they still have no impedance. The caller will call back when they are able to exchange the smartablate generator. The caller called back and they are using a demo smartablate generator and they are still not getting any impedance. A css(rh) was called to further troubleshoot. The caller confirmed a new catheter and cable are being used and the issue persists. The generator was still not showing any impedance. The caller was advised to replace the grounding pads with new pads and different lot numbers. When they unplugged the grounding pad, they get some artifact which is typically seen when they are not plugged in. The on-call biosense webster, inc. Field representative (kh) was called to further troubleshoot. The caller was advised the local biosense webster, inc. Field representative will need to be dispatched for the unresolved issue. The biosense webster, inc. Field representative confirmed all the steps that were taken and all cables that were exchanged were new. The piu was serviced last thursday 10/15/20. The caller states the issue started about mid-case and on the eleventh ablation and the ablation stopped. The caller was advised to replace the grounding pads again, but the caller states the physician was done with the case. The communication 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. On (b)(6) 2020 the clinical specialist notified that the procedure was aborted. On (b)(6) 2020 the bwi representative confirmed that the patient was under general anesthesia and transseptal was already performed before the procedure was aborted. No injury occurred. The physician only opined to the risk of the patient. The patient was discharged and will return to complete the ablation. After review of the additional information received on 10/30/2020, the procedure cancellation was assessed as mdr reportable for procedure cancellation with high patient risk. The awareness date for this reportable assessment is (b)(6) 2020.
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Manufacturer (Section D)
33 technology drive
irvine CA 92618
Manufacturer (Section G)
4 hatnufah street
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
MDR Report Key10901061
MDR Text Key219527379
Report Number2029046-2020-01806
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
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 Received12/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse