Model Number 2AF283 |
Device Problem
Contamination (1120)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010)
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Event Date 07/24/2015 |
Event Type
Injury
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Manufacturer Narrative
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This event occurred outside the u.S.Where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Investigation is in progress.Results of investigation will be submitted in a supplemental report.(b)(4).
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Event Description
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It was reported that during a cryo ablation procedure, an error code had occurred indicating that the safety system detected fluid in the catheter and stopped the injection.It was noted that the catheter was de-sterilized by error.The catheter was replaced.It was further reported that the patient experienced decreased blood pressure and an echocardiography (echo) showed a pericardial effusion.The procedure was aborted and the patient was treated with drainage of the effusion.The patient was under general anesthesia and there were no patient complications reported.
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Manufacturer Narrative
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Product event summary: data file analysis did not demonstrate a system notice related to the adverse event.A known clinical adverse event occurred during the procedure.No product was returned for analysis.
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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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