ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; INTRODUCER, CATHETER
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Model Number 406849 |
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 08/30/2022 |
Event Type
malfunction
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Event Description
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During the atrial fibrillation procedure, after being inserted, air was aspirated from the sheath when drawing back the syringe.It was noted that the sheath continued to produce air so the sheath was exchanged.The procedure was completed with no adverse patient health consequences.
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Manufacturer Narrative
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Additional information: d9, g3, h2, h3.One 8.5f fast-cath introducer sheath was received for evaluation.The dilator was also received.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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