ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL INTRODUCER, SL0, 8.5 F; TRANSSEPTAL CATHETER INTRODUCER
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Model Number G407376 |
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 11/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results, method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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During the procedure, an air leak occurred.While inserting the death, air was aspirated from the hemostasis valve.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
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Manufacturer Narrative
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One 8.5f swartz braided introducer sheath was received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.
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Search Alerts/Recalls
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