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Catalog Number 4004C1135 |
Device Problems
Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.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 m1 of the middle cerebral artery (mca) using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance while advancing a pc400 through a px slim delivery microcatheter (px slim) and, consequently, the pusher assembly of the pc400 became kinked.The physician therefore removed the pc400, and the procedure was completed using a new pc400 and the same microcatheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: the returned device was fractured approximately 35.0 cm and 54.0 cm from proximal end of the pusher assembly.The distal part of the fractured pusher assembly was not returned.The detached embolization coil had some offset coil winds.Conclusion: evaluation of the returned device revealed the pc400 pusher assembly was fractured and part of the device pusher assembly was not returned.If the device is forcefully advanced while experiencing resistance, damage such as a kink may occur.If the damaged device is further manipulated, the kink may eventually worsen to fracture.Based on the reported complaint, the fractures are likely incidental to the complaint and may have occurred post-procedure during packaging for return to penumbra.The px slim was not returned for evaluation; therefore, the root cause of the initial resistance was unable to be determined.Penumbra coils 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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Search Alerts/Recalls
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