Model Number 2AF284 |
Device Problems
Suction Problem (2170); Device Displays Incorrect Message (2591); Protective Measures Problem (3015); Temperature Problem (3022)
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Patient Problem
Pericardial Effusion (3271)
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Event Date 09/17/2015 |
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, a system notice was received indicating that the safety system detected a compromised outer vacuum.The catheter and coaxial umbilical cable were changed which resolved this issue.Additionally, a system notice was received indicating that the system detected a temperature drop during the system flush, and the system flush was stopped.The cryoconsole unit was rebooted without resolve.It was confirmed that the healthcare professionals were using a saline/contrast flush and that the temperature was reading 31.The healthcare professional was instructed to hold off on the flush and they were able to pass the integrity test.The cryoconsole unit appeared to be functioning normally at that time of the first ablation.The case was then aborted due to a pericardial effusion noted on intracardiac ultrasound.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Correction.
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Manufacturer Narrative
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Product event summary: data file analysis was performed.The data files also showed at least one injection was performed with the balloon catheter.No product has been returned for analysis.An adverse event was encountered during the procedure.In conclusion, an adverse event occurred during procedure (pericardial effusion) and the catheter was not returned for analysis.
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Search Alerts/Recalls
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