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.This report is associated with mfr report numbers: 3005168196-2018-00850, 3005168196-2018-00852.The hospital disposed of the device.
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The patient was undergoing a coil embolization procedure for a vessel sacrifice using penumbra coils 400 (pc400¿s) and a penumbra coil 400 detachment handle (handle).During the procedure, while advancing a pc400 through a px slim delivery microcatheter (px slim), the hospital fellow was too aggressive and inadvertently bent the pc400 pusher assembly; therefore, it was removed.It was reported that another pc400 pusher assembly was also bent while advancing the pc400 through the px slim; therefore, it was removed.The procedure continued using additional coils.Around the 30th coil, it was reported that blood might have gotten inside the handle and its the trigger became a bit sticky; therefore, the handle was set aside.The procedure was completed using the same px slim, a new handle and additional pc400's.There was no report of an adverse effect to the patient.
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