Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Vascular System (Circulation), Impaired (2572); Pericardial Effusion (3271)
|
Event Date 01/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
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 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.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The overall baseline gender/age characteristics is male/59 years old.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿acute outcome after a single cryoballoon ablation: comparison between arctic front advance and arctic front advance pro: short title: comparison of second- and fourth-generation cryoballoons¿ doi: 10.1111/pace.13718.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system: there was a total of five (5) patients who experienced phrenic nerve palsy (pnp); all of which fully recovered prior to hospital discharge.There was one (1) patient who had pericardial effusion; with unknown treatment/resolution.There was one (1) patient who had a vascular complication; 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 serial/lot numbers.The status/disposition of the cryoablation 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.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information obtained through follow up with the author indicated that none of the adverse events mentioned in the article were "related directly" to the products.No further information was available/provided.
|
|
Search Alerts/Recalls
|