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Catalog Number 4002C2060 |
Device Problems
Failure to Advance (2524); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The product was disposed of by the hospital and is no longer available for return.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.
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Event Description
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The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra coil 400s (pc400s).It was reported that the patient¿s vessel was slightly calcified and was tortuous.During the procedure, the physician felt a strong touch of "scratching" and was unable to advance a pc400 more than about 30 cm into the px slim delivery microcatheter (px slim); therefore, the px slim was removed with the pc400 inside.The pc400 was removed from within the px slim, and the procedure was then completed using six new pc400s and the same px slim.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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