Model Number ROTAREX®S 6F X 110CM |
Device Problems
Loss of or Failure to Bond (1068); Break (1069); Fracture (1260); Device Damaged by Another Device (2915); No Flow (2991)
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Patient Problems
Thrombosis (2100); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2020 |
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 sfa.Anterograde puncture was performed.Straub guildwire was used.Syringe was used to flush the catheter before inserting into the body.Guildwire reached 15cm beyond the thrombosis.Catheter reached 2cm before the thrombosis and started the motor.At the beginning, blood was found flowing out.After around one minute, no blood flow was found.Withdraw the catheter, it was found broken at the head.Pta was used to the patient and complete the operation.
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Manufacturer Narrative
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Evaluation summaty signed on 06/19/2020.
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Manufacturer Narrative
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Added data to d8 and d9 and correction of h6.
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Search Alerts/Recalls
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