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.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: the hidden skills of the cryoballoon: occlusion of cardiac perforation in a patient with persistent left superior vena cava¿a case report.European heart journal (2020) 4, 1¿5.Doi: 10.1093/ehjcr/ytaa056.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding use of cryoballoon guided occlusion of a cardiac perforation at the transseptal puncture site as an interventional rescue strategy.The authors discussed a case when the sheath was retracted into the right atrium there were clinical signs of cardiac tamponade; there was a rapid drop in blood pressure, compensatory sinus tachycardia and blood flow stasis in the internal jugular vein.The patient underwent urgent pericardiocentesis with placement of a pigtail catheter and aspiration of the hemorrhagic pericardial effusion.Aggressive fluid and therapy were applied; however, the patient continued to rapidly deteriorate and there were indications of a massive perforation.It was determined to advance a steerable sheath into the coronary sinus ostium followed by introduction of a balloon.Angiography showed there was complete occlusion of the perforation site.Two days later the patient was discharged without any sequelae.The disposition of the products is not known.Further follow up did not yet yield any additional information.
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