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Model Number 6207-S1 |
Device Problems
Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during the implant procedure, the introducer was kinked at the proximal end, the guide could not be introduced and the introducer broke in half during splitting/peeling.The introducer was replaced. no patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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