Continuation of medical devices: arctic front advance cardiac cryoablation catheter medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age of the patients represented in the article is male/(b)(6).Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: ¿time-to-isolation guided titration of freeze duration in 3rd generation short-tip cryoballoon pulmonary vein isolation ¿ comparable clinical outcome and shorter procedure duration.¿ international journal of cardiology 255 (2018) 80¿84.Https://doi.Org/10.1016/j.Ijcard.2017.11.039.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following patient complications while using a cryoablation balloon/sheath catheter/mapping catheter: there were two (2) patients who experienced cardiac tamponade/pericardial effusion; with unknown treatment/resolution.The s tatus/location of the cryoballoon catheter/sheath catheter/mapping catheter is unknown.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.
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