Continuation: 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).The model listed in the report is a representative of the (b)(6), 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: ¿outcome in patients with left common pulmonary vein after cryoablation with second generation cryoballoon.¿ pacing and clinical electrophysiology.2017.Doi:10.1111/pace.(b)(4).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 three (3) patients who experienced access site/groin complications with unknown treatment/resolution.There was also one patient who experienced phrenic nerve palsy (pnp) which resolved during follow up.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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