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Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Embolism (1829)
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Event Date 06/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The overall baseline gender characteristics is male; the age of the patients was approximately 66 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: ¿pulmonary vein isolation with the cryoballoon in obese atrial fibrillation patients ¿ does weight have an impact on procedural parameters and clinical outcome?¿ international journal of cardiology 316 (2020) 137¿142.Https://doi.Org/10.1016/j.Ijcard.2020.06.001.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The literature publication reported the following patient complications during a procedure using a cryoballoon ablation catheter system.There were patients who experienced ¿permanent¿ phrenic nerve palsy (pnp), stroke/ transient ischemic attack (tia), bleeding, and an embolism.All 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/serial 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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Search Alerts/Recalls
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