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Model Number 2FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
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Event Date 10/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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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/64 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/serial 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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: early recurrence of atrial fibrillation after pulmonary vein isolation: a comparative analysis between cryogenic and contact force radiofrequency ablation.Journal of interventional cardiac electrophysiology.2019; doi:// 10.1007/s10840-019-00639-3.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 catheter system: there were patients who experienced access site complications of hematomas, bleeding, and pseudoaneurysms.There were also patients with infections; which required antibiotics.There was one patient who suffered a stroke; with no indication of any residual effects.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/disposition of the cryoablation 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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Search Alerts/Recalls
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