This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/65 years old.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: transseptal puncture for left atrial ablation: risk factors for cardiac tamponade and a proposed causative classification system.Journal of cardiovascular electrophysiology.2022;1¿9.Doi: 10.1111/jce.15590.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding cryoballoon ablation and cardiac tamponade.The article reports patients who experienced cardiac tamponade either intra or post ablation procedure.Cardiac tamponade was diagnosed following an attempted transseptal puncture (tsp) with the needle or guidewire, following passage of the sheath(s) beyond the interatrial septum, immediately following withdrawal of sheaths on conclusion of the procedure, during ablation treatment or during manipulation of the ablation catheter, or during recovery from the procedure.Some patients required surgical drainage via median sternotomy or pericardiocentesis, other intervention included a stepwise combination of protamine, concentrated clotting factors, vitamin k, fresh frozen plasma or cryoprecipitate was administered or acquired coagulopathy or blood transfusion.The status/disposition of the catheters, needles, and sheaths is unknown.No further patient complications have been reported as a result of this event.
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