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 disposed of the device.
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During preparation for a coil embolization procedure, the hospital staff found that the pusher assembly of the ruby coil was kinked upon removal from the packaging.The damage to the ruby coil was found prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using additional coils.
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