Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The reported lot number was confirmed from the returned packaging.On visual inspection, 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.On visual inspection, the balloon catheter was kinked at 19cm & 26cm from the proximal end.On functional testing, an attempt was made to inflate the balloon; however, the balloon was unable to be inflated.The reported event was confirmed.The device was returned for analysis and the balloon catheter was found kinked/bent and the balloon failed to inflate.In the case of this complaint it is most likely that the device was damaged during the procedure due to some procedural/anatomical factors.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore an assignable cause of procedural factors will be assigned to the and to the as reported defect balloon difficult/unable to deflate during use and the analyzed defects balloon catheter shaft kinked/bent and balloon failed to inflate.
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