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 Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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During an atrial fibrillation procedure, after placing the sheath into the patient and prior to inserting any catheters or the transseptal needle, air was aspirated into a syringe that connected to the extension port of the sheath.Several aspirations were attempted, but the issue remained.The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.
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Manufacturer Narrative
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Additional information: d9, g3, h2, h3, h6.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.
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Search Alerts/Recalls
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