Model Number SET ROTAREX®S 6F X 110CM |
Device Problems
Defective Device (2588); Mechanical Jam (2983)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Suspect device not returned yet.Company representative and user will be contacted again if this sample can be returned for investigation.
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Event Description
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Initially the rotarex catheter was working well when inserted into the patient for atherectomy of the sfa.After a minute or two of use the rotarex catheter would not activate properly and create helical vortex.Flow was not being carried through the archimedes screw throughout the rotarex to the collection bag.An audible change in pitch was recognized and trying to use the "return" and flush procedures detailed in the ifu did not seem to work and the catheter was not used to complete the procedure.No harm to the patient.Intervention was completed with balloons and guiding catheters.
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Search Alerts/Recalls
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