Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual/microscopic inspection: the device was kinked.Severely kinked at the proximal end.Functional test: the balloon catheter was hydrated, and no anomalies were noted to the outer surface.An attempt was not made to advance the balloon catheter through a guide catheter, as the damage noted would not allow passage.The reported event is covered in the device directions for use (dfu).The risk of the reported event is documented in the risk documentation.The event description states that the gateway could not pass through stenosis and it bent.At that time bleeding was experienced.The device was returned for analysis and the balloon catheter shaft was noted to be extensively kinked.It is probable that the balloon catheter was damaged due to the difficulty to pass through the stenosis causing the bleeding at the site of the stenosis.An assignable cause of procedural factors will be assigned to the reported patient hemorrhage, blood loss with sequelae, balloon catheter kinked/bent and device difficulty engaging target vessel and to the analyzed balloon catheter kinked/bent, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
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