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Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Pseudoaneurysm (2605)
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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/62 years old.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/methods/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.Referenced article: ¿ice or fire? comparison of second-generation cryoballoon ablation and radiofrequency ablation in patients with symptomatic persistent atrial fibrillation and an enlarged left atrium.¿ journal of cardiovascular electrophysiology.2017.Please cite this article as doi: 10.11 11/jce.13402.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 complication while using a cryoablation balloon/sheath catheter/mapping catheter: there were two (2) patients who experienced phrenic nerve palsy (pnp), and were given oral medication to manage it.There were patients who experienced groin complications, ¿minor¿ groin hematomas, pseudoaneurysms, and transient ischemic attacks (tias)/strokes; all with unknown treatment/resolution.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/methods/product lot numbers.The status/location of the cryoballoon catheter/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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