Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010)
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Event Date 02/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 experienced hypotension.The physician confirmed a pericardial effusion and the procedure was aborted.A pericardiocentesis was performed with patient recovery.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received indicated the physician associated the adverse event to the transseptal puncture.Therefore, the manufacturer's products were not in the heart at this time.There is no indication that the transseptal needle used was the manufacturer's product.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Further information received indicates that the transseptal needle was not the manufacturer's product.
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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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