Medtronic was made aware of this event through a search of literature publications.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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: ¿life-threatening massive hemoptysis after cryoablation for atrial fibrillation.¿ j bronchology interv pulmonol.2017 sep 14.Doi: 10.1097/lbr.0000000000000417.
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The literature publication reports the following patient complications while using a cryoablation balloon.A patient presented one month post-ablation procedure with chest pressure, bleeding from the nose, and ¿recurrent¿ hemoptysis.The patient also stated that there was worsening ¿exertional dyspnea¿ since the ablation procedure.Of note, the patient had presented to the emergency room (er) one week prior with similar complaints revealed no abnormalities.Upon admission to the hospital, the patient developed ¿severe¿ bleeding from the nose, which was treated and the patient had ¿temporary hemostasis.¿ later the same day, the patient had more bleeding from the nose and ¿massive hemoptysis causing severe respiratory compromise during intubation.¿ the patient then underwent emergency tests and active bleeding, clots were seen.A ¿massive¿ transfusion was initiated.The patient¿s hemoptysis was resolved.The patient had a repeat bronchoscopy performed which showed an area of ¿ulceration,¿ which was missed due to the blood obstructing the view.The author indicated that the ulcer ¿most likely¿ resulted from the ¿cryoablation-induced bronchial injury.¿ the patient was dis charged and remained asymptomatic.Two months later, the patient underwent a follow-up bronchoscopy and it appeared that the ulcer was ¿healing.¿ the status/location of the cryoballoon is unknown.No further patient complications have been reported as a result of this event.
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