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
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
Event Type
malfunction
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Event Description
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Related manufacturing ref: 3005334138-2021-00371, 3005334138-2021-00373, 3005334138-2021-00374.During the procedure, insertion difficulties were noted and a delay in procedure occurred.The needle could not be advanced through the sheath due to resistance.This was attempted with three additional sheaths unsuccessfully.A fifth sheath was obtained, and the needle was advanced to complete the procedure with no consequences to the patient.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported insertion difficulties and subsequent delay remain unknown.
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Search Alerts/Recalls
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