During the af ablation procedure, the user set up the temperature monitoring probe (26155st lot 23cb0078) in nasal cavity but that was a failure.They tried to place the probe orally, but an epistaxis appeared.At the end of the procedure, the epistaxis intensified requiring an embolization to stop the bleeding.The patient had to be moved to intensive care.
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1.The event occurred in eu (france) not in us.2.The product reported involved in the incident - model 26155st - is similar to the product cleared for the marketing in us under the 510(k) k123361 and model 26155s/us, however this latter is not sold in the us since 2019 and currently dismissed in fiab portfolio.3.The sample of the device involved in this incident is not available yet, but is being returned to fiab for examination.The preliminary assessment is based on the available information and it's expected to be confirmed after the device return, unless the returned probe will show severe defectiveness / non compliance with expected specifications (i.E.From a dimensional standpoint or the presence of anomalies on shape, presence of sharp edges etc).4.It is deemed not correct identifying the probe 26155st itself as the cause of the epistaxis event, instead of considering the epistaxis as a possible and expected occurrence during any kind of tool introduction inside a highly vascularized body area.There is no inherent characteristic of the probe 26155st itself that can cause damage other than its friction against delicate tissues caused by a rough introduction or previously.Moreover the information from the healthcare facility indicates that the patient was under anti-coagulant treatment and this is a key factor that can prolonge / increase the epixtasis.
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