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Catalog Number RBY2C1857 |
Device Problems
Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was intact with the pusher assembly within the introducer sheath, and was compressed and offset on the proximal end.Dried blood was observed throughout the introducer sheath and embolization coil.During functional analysis, the ruby coil could not be advanced through its introducer sheath due to the compressed and offset coil winds.Conclusions: evaluation of the returned device revealed the embolization coil was intact with the pusher assembly.Therefore, the reported unintentional detachment could not be confirmed.Further evaluation revealed the embolization coil was compressed.This damage may have occurred due to forceful advancement of the ruby coil against resistance.The root cause of the initial resistance experienced during advancement could not be determined.The kinks observed throughout the pusher assembly were likely incidental and may have occurred during packaging for return to penumbra.Dried blood was observed throughout the introducer sheath and embolization coil.If a rotating hemostasis valve (rhv) and continuous flush are not used, blood may be more likely to dry throughout the introducer sheath and embolization coil.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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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The patient was undergoing a coil embolization procedure to treat a type ii endoleak using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and retracted the coil.While attempting to re-advance the ruby coil, resistance was encountered again and upon retraction, the ruby coil unintentionally detached within the microcatheter.Therefore, the ruby coil pusher assembly was removed and the detached coil was aspirated out of the microcatheter.The procedure was completed using seven additional ruby coils, the same microcatheter and a 3cc flush syringe with no issues.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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