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 age of the patients represented in the article is 68 years 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.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: efficacy and safety of the second generation cryoballoon ablation for the treatment of paroxysmal atrial fibrillation in patients over 75 years: a comparison with a younger cohort.Europace (2017) 19, 1798¿1803.Doi:10.1093/europace/eux023.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 catheter system: there were eleven (11) patients who experienced persistent or transient phrenic nerve palsy (pnp), with unknown treatment/resolution.There was one (1) patient with a groin hematoma which did not require any intervention, and one (1) patient with a femoral pseudoaneurysm that required intervention via thrombin injection.The status/location of the cryoballoon catheter system is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
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