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Catalog Number RBY2C1035 |
Device Problems
Bent (1059); Device Handling Problem (3265)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the ruby coil pusher assembly was kinked approximately 5.0 cm from its proximal end.Conclusions: evaluation of the returned ruby coil revealed a kink on the proximal end of the pusher assembly.This damage is likely a result of the technologist inadvertently bending the pusher assembly while removing it from the packaging hoop.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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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While preparing a new ruby coil for a coil embolization procedure, the technologist inadvertently bent the ruby coil pusher assembly while removing the coil from its dispenser hoop.The pusher assembly became bent prior to use and therefore, the ruby coil was not used for the procedure.The procedure was completed using five new ruby coils.
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Search Alerts/Recalls
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