MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 990063-015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Cardiac Tamponade (2226); Vascular System (Circulation), Impaired (2572)
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Event Date 12/04/2019 |
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 63 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: ¿cryoablation for persistent and longstanding persistent atrial fibrillation: results from a multicentre european registry.¿ europace.2020 mar 1;22(3):375-381.Doi: 10.1093/europace/euz313.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 four (4) patients who experienced cardiac tamponade; which required drainage, but no surgical intervention.There were 19 patients who had phrenic nerve palsy (pnp), all of which had recovered with eight (8) months post-procedure.There was one (1) patient who had a transient ischemic attack (tia) post-procedure, with no further recurrence or stroke.One (1) patient had an access site hematoma; which was managed conservatively.This complication delayed hospital discharge date.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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