Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultraverse rx device was received for evaluation, the device guidewire lumen was attempted to be flushed but was unsuccessful.An inhouse guidewire was attempted to be inserted but was unable to be fully inserted.The device was cut and under microscopic examination an unknown object was noted within the guidewire lumen.The material was noted to likely be the inner most layer of the inner lumen separating from the catheter.Therefore, the investigation is confirmed for the reported guidewire insertion issue, as a device guidewire was unable to be fully inserted through the device.The investigation is also confirmed for the identified material separation, as the inner lumen was noted to be separated and blocking the guidewire lumen.The definitive root cause of the identified material separation and guidewire insertion issue could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 04/2023).
|