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Catalog Number 4004C0830 |
Device Problems
Failure to Fold (1255); Structural Problem (2506); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/15/2016 |
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 internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed a pc400 coil into the aneurysm; however, the coil was not taking the intended 3d coiling pattern.Subsequently, the pc400 coil was removed from the patient.The physician then advanced the coil out into a bowl of saline and found that it came out straight and did not coil into a 3d pattern.Therefore, the procedure was completed using a new pc400 coil and another manufacturer's coils.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 penumbra coil 400 (pc400) pusher assembly; the embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device confirmed that the pc400 complex shape was present.The pc400 was deployed in a warm cup of water to simulate the body temperature and the intended shape was observed.Therefore, the pc400 was functional.The root cause of this complaint could not be determined.All 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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Search Alerts/Recalls
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