ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER
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Model Number 407362 |
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 05/04/2022 |
Event Type
malfunction
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Event Description
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During an ablation for atrial tachycardia, air leak was noted.The sheath was replaced and the procedure was completed without any patient consequences.
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Manufacturer Narrative
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One 8.5f swartz braided introducer sheath was received for evaluation.The dilator was also received.Functional testing confirmed an air leak in the hemostasis valve.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 remains unknown.
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Search Alerts/Recalls
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