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Catalog Number RBYPODJ60 |
Device Problems
Material Deformation (2976); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted out of the ddt.If this occurs, by design the embolization coil will detach from the pusher assembly.Further evaluation revealed multiple pusher assembly kinks and fractures.This damage is incidental to the reported complaint and may have occurred during packaging of the device for return.Penumbra products are visually 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 in the internal iliac artery (iia) using pod packing coils (pod pcs) and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted one pod pc into the target location.While advancing the next pod pc through the middle of the microcatheter, the physician kinked the proximal end of the pusher wire.Subsequently, the pod pc unintentionally detached in the middle of the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed from the patient and the coil was flushed out on the back table.The procedure was completed using another pod pc of the same size, seven additional pod pcs, and the same microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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