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Catalog Number 4004C0513 |
Device Problems
Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Unintended Movement (3026)
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Patient Problems
No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted into the patient.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra coil 400''s (pc400's).After deploying and detaching the last pc400 of the procedure, the physician removed the px slim delivery microcatheter (px slim) out of the patient and subsequently, the end of the pc400 migrated down into the parent artery.The physician then attempted to use a stent device but was unable to successfully place it.Therefore, the physician left the single loop of the pc400 protruding out of the aneurysm since he did not believe that it would cause any problems.The patient was then placed on plavix and the procedure was completed.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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