This report is being submitted as follow up no.1 to provide additional information to section b5, update section d9, section h3, and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.There was no anomaly confirmed in the relevant historical record.As a cause of the reported event, it was presumed that the actual sample was exposed to an excessive tensile load, which resulted in the fracture.Since no actual sample was returned for analysis, the definite cause of occurrence could not be determined.Ashitaka factory manufacturing process maintains the product quality by performing the following operation and inspections: i) in the tube molding process, the shaft was formed on the od-controlled core wire and then the core wire was removed so that the inner diameter of the shaft is assured; ii) before the packaging process, 100% visual inspection of the catheter is performed to assure that there is no anomaly including a crush; iii) in the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect the product and to prevent the occurrence of the crush.Please refer to the following warning indicated in the ifu (instructions for use) of this product: directions 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.".
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