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Model Number G407371 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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During the procedure, air was aspirated into a syringe that connected to the extension port of the sheath after placing the sheath into a patient.Several attempts were made, but air was still aspirated.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.No additional puncture was required for replacing the sheath.
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Search Alerts/Recalls
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