There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, distal part of the balloon catheter was found to be flattened/crushed.The tip of the balloon catheter was found to be damaged.During functional inspection, the balloon could not be inflated due to damage to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was described as 'severely tortuous'.During inspection the catheter shaft (distal section) was noted to be damaged (flattened/crushed).The distal tip of the balloon catheter was also damaged.It was not possible to inflate the balloon due to the condition of the returned device.The as reported event of balloon difficult/unable to deflate during use and the as analysed events of balloon failed to inflate, balloon catheter tip damaged and balloon catheter flat/crushed will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
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