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Catalog Number FG540000 |
Device Problem
Image Orientation Incorrect (1305)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.Manufacture reference no: (b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure with a carto® 3 system, and a map shift issue occurred.During ablation procedure, the physician noticed a map shift without any error message on carto 3 system.According to the initial fast anatomical map (fam), the 20 poles on the pentaray nav high-density mapping catheter were not in an accurate position when in the veins.Extended features were turned on and patch placement was looked at.Initially it was reported, that one of the back patches moved by 4.3mm approximately according to the values and the other 2 back patches where in exact same position.Clarification was received indicating that upon examination, one of the back patches had moved about 0.5cm relative to the other.The physician asked for fam of the veins again, to make sure he was in a good position to burn.No error message was displayed and the map was recreated with a minor 4 minute procedure delay.No patient consequence was reported.There was no patient movement or cardioversion.The issue of a map shift without patient movement, cardioversion or error messages is considered mdr reportable.
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Manufacturer Narrative
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It was reported that a patient underwent an ablation procedure with a carto® 3 system, and a map shift issue occurred.During ablation procedure, the physician noticed a map shift without any error message on carto 3 system.The investigational analysis completed 8/20/2019.The data related this issue was provided to manufacture and investigated.The data provided to the manufacture was not sufficient for investigation.Reported issue was not reproduced with provided data.Preventative maintenance performed during site visit by field service engineer (fse).No issue was found.Fse confirmed that the system passed all required tests (acceptance testing procedure and fluro influence on the magnetic catheter location stability) and found is fully functional.System is operational.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacture reference no: (b)(4).
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Search Alerts/Recalls
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