Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Date 01/01/2018 |
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.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 numbers.The baseline age characteristic is 67 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: ¿posterior wall isolation using the cryoballoon in conjunction with pulmonary vein ablation is superior to pulmonary vein isolation alone in patients with persistent atrial fibrillation: a multicenter experience.¿ heart rhythm 2018;15:1121¿1129.Https://doi.Org/10.1016/j.Hrthm.2018.05.014.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 the use of a cryoballoon ablation system: there were patients who experienced persistent phrenic nerve palsy (pnp), pericardial effusion, and vascular complications.There was no indication of treatment/resolution.Further follow up did not yet yield any additional information.The status/location of the cryoballoon system is unknown.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was obtained through follow up with the author/physician who indicated that the issues presented were not related to the products.No further information was provided.
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Search Alerts/Recalls
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