The actual device has been returned for evaluation.Visual inspection of the actual sample (unaided eye, microscope, and electron microscope).The fracture was located near the distal end.The shaft had been fractured diagonally.The fractured edges of the distal and proximal portions matched in shape with each other, suggesting that there was no missing portion.There were scratches at the extension of fractures of both portions.Dimensions of the actual sample: the inner and outer diameters at the undamaged part were confirmed to meet the factory's specifications.No anomaly was observed.(cause of occurrence): no anomaly was found in the manufacturing history and product dimensions.Based on the situation at the time of occurrence and the condition of the actual sample, one possibility was that the catheter was scratched due to having been exposed to the biopsy device and fractured starting from this scratch when exposed to pulling force during subsequent manipulation.(countermeasure): ashitaka factory assures the quality of this product by performing following work and controls.After the shaft is molded on the core wire whose outer diameter is controlled, the core wire is removed to assure the inner diameter of shaft.Before the packaging, 100% magnifying inspection is performed to confirm that there is no anomaly such as a kink or a tear on the catheter.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect the product and to prevent a kink or a tear.The ifu of this product provides the following information.[instruction for use] the radifocus glidecath should be used by a physician who is well trained in manipulation and observation under fluoroscopy.[direction for use]warning: never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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