Concomitant medical products: 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 patient or 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 model listed in the report is a representative of the model family, as there is no specific model listed.The gender of the baseline characteristics is male and the baseline age is (b)(6) old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.Without a lot number or device serial number, the manufacturing date cannot be determined.Referenced article: ¿second-generation cryoballoon ablation for treatment of persistent atrial fibrillation: three-year outcome and predictors of recurrence after a single procedure.¿ journal of cardiovascular electrophysiology.2017.Doi:10.1111/jce.13372.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 was one (1) patient who experienced a groin hematoma which was managed ¿conservatively.¿ there were two (2) patients who experienced phrenic nerve palsy (pnp); all of which made a full recovery by hospital discharge.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 status/location of the cryoballoon/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.
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