ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL INTRODUCER, SL0, 8.5 F; TRANSSEPTAL CATHETER INTRODUCER
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Model Number G407376 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2020 |
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, after placing the introducer into the patient, prior to inserting any catheters into the introducer, blood began to leak from the hemostasis valve of the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.No additional puncture was required for replacing the introducer.
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Manufacturer Narrative
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One 8.5f swartz braided introducer sheath was received for evaluation.A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak is consistent with damage during use.
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Search Alerts/Recalls
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