Model Number SET ROTAREX®S 6F X 135CM |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Suspect device not returned yet.The return of suspect device is expected.
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Event Description
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Thrombosis was found in both illiac artery.Introduction was carried out through brachial artery.Catheter was flushed with guildwire before intruding into the human body.After that, catheter reached the 1cm before the lesion.Thrombosis in the left illiac artery was cleared away.Withdraw the catheter for flushing.Tip of the catheter head was found broken and left in the artery.Snare was used to take the remains out.Balloon and thrombolysis catheter were used to complete the operation.
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Manufacturer Narrative
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Summary evaluation report attached.
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Search Alerts/Recalls
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