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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 01/01/2018 |
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.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/65 years old.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 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: ¿acute and long-term efficacy and safety with a single cryoballoon application as compared with the standard dual application strategy: a prospective randomized study using the second-generation cryoballoon for pulmonary vein isolation in patients with symptomatic atrial fibrillation.¿ europace (2018) 00, 1¿8.Doi:10.1093/europace/euy014.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 was one patient who experienced cardiac tamponade, which required ¿acute pericardiocentesis.¿ there were also patients who experienced pericarditis, ulcus/dyspepsia, phrenic nerve palsy (pnp), transient ischemic attack (tia), stroke and gastroparesis.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.No further information was provided.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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