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Catalog Number RBY4C0315 |
Device Problems
Bent (1059); Kinked (1339); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Results: the ruby coil pusher assembly was kinked approximately 5.0 and 67.0 cm from the proximal end.Conclusions: evaluation of the returned ruby coil revealed two kinks along the pusher assembly length.The proximal kink was likely a result of forcefully removing the ruby coil from the packaging hoop.The more distal of the two kinks was likely due to the returned packing condition.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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During preparation for a coil embolization procedure, the radiologic technologist noticed that the ruby coil pusher assembly was bent/kinked near the pet lock upon removal from the packaging.The damaged ruby coil was found prior to use and therefore, was not used in the procedure.The procedure was completed using another ruby coil.
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Search Alerts/Recalls
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