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 hospital discarded the device.
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The patient was undergoing a coil embolization procedure in the ovarian vein using pod packing coils (podjs).During the procedure, the physician successfully placed a ruby coil using a non-penumbra microcatheter.The physician then attempted to place a podj, however, the podj unintentionally detached before the physician advanced it out of the microcatheter.The physician therefore removed the microcatheter with the podj inside, and the procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
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