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Catalog Number 4004C0513 |
Device Problems
Failure to Advance (2524); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2018 |
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 pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly and the stretch resistant wire was fractured (sr wire).Conclusions: evaluation of the returned pc400 revealed the sr wire was fractured and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance, and will allow the embolization coil to detach.A demonstration pc400 was advanced and retracted through the lantern without issue and, therefore, the root cause of the reported resistance could not be determined.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2018-00348.
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Event Description
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The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached five pc400s slightly proximal at the distal bifurcation of the right iia aneurysm using the lantern.While advancing a new pc400 through the lantern, the physician noticed that the pc400 was unable to fully advance out of the lantern and became stuck.Upon attempting to retract the pc400, it unintentional detached within the lantern.The lantern was therefore removed, and the physician pulled the pc400 out, and then reinserted the same lantern.Next, the physician attempted to advance a new pc400, however the pc400 was unable to advance and became stuck again.Upon attempting to retract the pc400 it unintentionally detached.The physician therefore removed the lantern with the pc400 inside, and completed the procedure using a new microcatheter and a new coil.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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