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Catalog Number RBY4C0315 |
Device Problems
Failure to Advance (2524); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician placed the initial ruby coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new ruby coil into the microcatheter, the ruby coil appeared to be stuck in its introducer sheath.After a few failed attempts, the ruby coil was removed.The procedure was successfully completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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