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 coil was discarded by the hospital.
|
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400s).During the procedure, the physician was unable to advance a pc400 through its introducer sheath and into the px slim delivery microcatheter (px slim); therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
|