Model Number 4FC12 |
Device Problem
Gas/Air Leak (2946)
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Patient Problems
Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
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Event Date 07/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryoablation procedure,the patient's heart rate and blood pressure dropped.A fluoroscopy was performed and an air embolism was observed on the left side of the heart.Intervention was performed via emergency rescue program and air was removed.The procedure was aborted.The patient was noted to be awake, then transferred to the icu and had an extended hospitalization.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the device was intact with no apparent issues.The deflection worked as per specification.Several flushes and aspirations were performed with a test balloon catheter without issues.Aspiration/flush testing did not show any air passing through the tube or expelled from the distal tip of the sheath.In conclusion, the sheath passed the functional test as per specification.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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