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Model Number U5TRAN35SH |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2022 |
Event Type
malfunction
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Event Description
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During prep catheter was discovered to be defected.It has an imperfection which didn't allow the wire to go through the catheter.Catheter has a slight narrowing or bend that didn't allow a wire to pass.Manufacturer response for catheter, dxterity tran 3.5 diagnostic cath.5f x 0.038in x 100cm (x) (per site reporter).Clinical site corresponded with manufacturer directly.
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Search Alerts/Recalls
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