ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F; Introducer, catheter
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Model Number 407451 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Event Description
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During a mitraclip procedure, the dilator was punctured by the needle.While in the right atrium and performing the transseptal puncture, it was noted that the needle punctured through the side of the dilator and was free in the right atrium pointing toward the septum.The introducer was exchanged 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 and dilator were received for evaluation.The dilator had been perforated proximal to the distal tip.The dilator and sheath were flushed with fluid and the dilator was inserted into the sheath; no resistance or anomalies were noted.A needle/stylet assembly from current inventory was inserted and advanced through the dilator/sheath assembly; however, the needle could not advance past the location of the perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the punctured dilator remains unknown.
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Search Alerts/Recalls
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