(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date of event.Investigation of the devices could not be conducted as they were not returned.Although the device investigation and lot history review could not be conducted, there was no indication of product deficiency since all the shipped products are inspected in the production process and satisfied the product specifications and release criteria.Based on the provided information, it was presumed that such substance as blood or contrast media that had firmly adhered on the guide wire proximal shaft went into a concomitant device lumen, affecting lubricity between the guide wire and its concomitant device and eventually causing the two devices to get stuck each other.In order to prevent such an issue, it is strongly recommended to use heparinized saline to protect the guide wire surface from drying if the guide wire is temporarily taken out of the patient anatomy after use.Instructions for use states: special instructions for hydrophilic coated guide wires -preparations for use: after pulling the guide wire out of the body, wipe it off with gauze soaked in heparinized saline, and keep it wet.The device is manufactured by (b)(4).(b)(4) distributes the device and is responsible for mdr reporting.
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