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/weight of the patients represented in the article is male/65 years old/92 kg.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: ¿conscious sedation during cryoballoon ablation of atrial fibrillation: a feasibility and safety study.¿ minerva cardioangiologica 2018 april;66(2):143-51.Doi: 10.23736/s0026-4725.17.04505-4.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 catheter system: there were patients who had transient phrenic nerve palsy (pnp); all of which resolved within 12 hours of the procedure.There were also patients with vascular complications; with hospitalization and ¿conservative¿ treatment.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 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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