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Model Number RBYPODJ15-A |
Device Problems
Migration (4003); Physical Resistance/Sticking (4012); Separation Problem (4043)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a coil embolization procedure in the hepatic artery and gastric arteries using pod packing coils (pod pcs), ruby coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed ruby coils in the target vessels using the lantern.Next, while advancing the pod pc, it became stuck and unintentionally detached partially in the lantern and partially in the vessel.The physician then flushed the pod pc with a syringe; subsequently, it was placed in the vessel but not perfectly as the tail was left hanging out.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 42.0, 43.0, 46.0, 48.0, 131.5, 140.5 and 141.0 cm from the proximal end.The pet on the pull wire was advanced distally through the distal detachment tip (ddt) alignment feature.The proximal constraint sphere was not within the ddt.Conclusions: evaluation of the returned pod pc revealed that the pet lock was intact on the proximal end of the pusher assembly and the pull wire was slightly advanced distally through the ddt alignment feature.If the pod pc is advanced against resistance, the pet on the pull wire may protrude through the alignment feature, and the embolization coil may detach.The lantern identified in the complaint was not returned for evaluation; therefore, the root cause of resistance could not be determined.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the detachment issue.
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Search Alerts/Recalls
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