Model Number 2AFAST28 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Vascular Dissection (3160)
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Event Date 10/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that during a cryoablation procedure, positioning the cryoballoon system in the right inferior pulmonary vein (ripv), the patient's blood pressure began to drop and a cardiac tamponade was identified.Ct surgery was called to the lab and a successful maneuver was performed to remove the tamponade and stabilize the patient.The procedure was aborted.The patient underwent a repair of the ripv and the patient recovered the following morning.No further patient complications have been reported related to this event.
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Manufacturer Narrative
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Product event summary: data file analysis was performed on the balloon catheter (b)(4).The data files did not show any system notices on the reported date of event.Additionally, the data files showed at least eleven injections were performed with catheter.No product was returned for analysis.This was a clinical issue encountered during the procedure.No product malfunction was reported.In conclusion, there was no indication of product malfunction and no product to be returned.
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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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Search Alerts/Recalls
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