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Catalog Number RBY4C2060 |
Device Problems
Bent (1059); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2018 |
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 successfully placed multiple ruby coils using a lantern delivery microcatheter (lantern).The physician then felt resistance while attempting to advance another ruby coil within the lantern, and consequently the pusher wire of the ruby coil became bent.The ruby coil was therefore removed, and the procedure was then completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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