ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER
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Model Number 407453 |
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 04/13/2023 |
Event Type
malfunction
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Event Description
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During an atrial fibrillation ablation procedure, an attempt was made to insert the device for a transseptal puncture, and the needle pierced the dilator.The physician is not certain if it was due to the tortuosity of the vessel and the needle was not reshaped.The device was exchanged, and the procedure was completed with no adverse patient health consequences.
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Manufacturer Narrative
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One 8.5f swartz braided introducer dilator was received for evaluation.Visual inspection revealed the dilator was perforated 1.48¿ proximal to the distal tip.There were also multiple bends throughout the dilator.A needle/stylet assembly from current inventory was inserted and advanced through the dilator; however, the brk needle exited through the aforementioned perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported dilator puncture could not be conclusively determined.
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Search Alerts/Recalls
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