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 of the patients represented in the article is male/(b)(6).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: ¿is ¿¿bonus¿¿ application required after pulmonary vein isolation using second-generation cryoballoon catheter? a 1-year follow-up study.¿ https://doi.Org/10.1016/j.Acvdsp.2017.11.245.If information is provided in the future, a supplemental report will be issued.
|
The literature publication reports the following patient complications while using a cryoablation balloon/sheath catheter/mapping catheter: there were seven (7) patients who experienced transient phrenic nerve palsy (pnp) during the procedure.There were three (3) patients who experienced cardiac tamponade; with unknown treatment/resolution.There were also seven (7) patients in which pericardial effusion was observed; with unknown treatment/resolution.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/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.
|