Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the microcatheter shaft was found to be kinked and had a hole/perforation.The microcatheter tip was found to be damaged.Dimensional inspection confirmed the microcatheter dimensions were within specification.A functional test confirmed that a pin gauge met the catheter shaft when inserted into the hub and that a patency mandrel would not advance beyond the kink.The reported event is covered in the device direction 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 event 'catheter kinked/bent' was confirmed during analysis.The reported 'catheter, difficulty advancing coil' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The product was analyzed.The catheter shaft was found to be kinked which would have caused friction trying to advance the coil.During analysis there was a hole identified near the distal tip and the distal tip was damaged.The catheter most likely became damaged due to some procedural factors during the procedure.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 factors during use.The as reported 'catheter kinked/bent' and 'catheter, difficulty advancing coil' as well as the as analyzed 'catheter tip damaged', 'catheter shaft has hole/perforation' and 'catheter shaft kinked/bent' will be assigned procedural factors.
|