|
Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fistula (1862); Hematoma (1884); Muscle Weakness (1967); Pneumothorax (2012); Paresthesia (4421); Embolism/Embolus (4438)
|
Event Date 01/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/61 years old.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: effect of air removal with extracorporeal balloon inflation on incidence of asymptomatic cerebral embolism during cryoballoon ablation of atrial fibrillation: a prospective randomized study.International journal of cardiology heart <(>&<)> vasculature.40 (2022) 101020.Doi:10.1016/j.Ijcha.2022.101020.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
A journal article was reviewed that contained information regarding the effect of air removal with extracorporeal balloon inflation on incidence of asymptomatic cerebral embolism during cryoballoon ablation.The article reports patients who underwent an ablation procedure and experienced complications such as symptomatic cerebral embolism, arteriovenous shunt, and pneumothorax.Patients with symptomatic cerebral embolism had symptoms such as dysarthria, mild muscle weakness in one hand, left upper limb weakness, and left lower limb paresthesia.Their symptoms improved within one month and follow-up magnetic resonance imaging (mri) showed no evidence of cerebral hemorrhage or an exacerbation of cerebral embolism.There was no indication of any intervention performed for any of the complications.The status/disposition of the catheters and sheaths is unknown.No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|