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Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: 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/61years old.Of note, multiple patients/manufacturers were noted in the article; however, a one to one correlation could not be made with unique manufacturer/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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿cryoballoon ablation of atrial fibrillation in patients with advanced systolic heart failure and cardiac implantable electronic devices.¿ kardiologia polska.Polish heart journal.Published online: 2018-03-07.E-issn: 1897-4279.Doi: 10.5603/kp.A2018.0068.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 reports the following patient complications while using a cryoablation balloon/sheath catheter/mapping catheter: there were four (4) patients who experienced transient phrenic nerve palsy (pnp), all of which had recovered during the follow up period.There were two (2) patients who had pericardial tamponade requiring pericardiocentesis; after which, both had an ¿uneventful clinical course, and were discharged home.¿ 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/sheath catheter/mapping catheter 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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