Model Number 2AF284 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 09/16/2015 |
Event Type
Injury
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Manufacturer Narrative
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This event occurred (b)(6) where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that during a cryoablation procedure, tamponade was suspected as the patient's blood pressure declined to the seventies.Pericardial effusion was found through observation with the echocardiogram, and drainage was performed.It was noted that the cause was unclear.The case was completed with cryo.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 data files were returned and analyzed.The data files did not show any system noticed on the date of the reported event.No product was returned for analysis.A clinical issue was encountered during the procedure; no product malfunction alleged.In conclusion, there was no indication of a product malfunction and no product 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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