Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed; however, imaging was provided for review.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The photograph depicts a coated 0.035 inch diameter terumo glidewire partially inserted through the one-part percutaneous entry needle.There is a fully separated section of wire coating in the image which is approximately half the length of the needle.A portion of the wire coating has been partially peeled, and extends approximately half the length of the needle.It remains connected to the distal tip of the wire.The bevel of the needle is pushed as far forward as the point here the coating separation begins, giving the appearance that the wire was withdrawn through the needle.Based on the needle's specified dimensions and the specified dimensions of the stylet checker, a 0.035 inch diameter wire should fit through the lumen of this needle without difficulty within normal use, although we do not have diameter and tolerance information for the terumo glidewire.The mdx-silicone coating of the needle may also serve to facilitate passage.The needle is inspected for dents and burrs during the manufacturing process, and the stylet checker must pass freely through the lumen with a smooth transition.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined; however, it is likely that this event can be attributed to handling/ user technique as it appears that the coated wire was withdrawn through the needle.Risk assessment was not performed as there is no indication based on available information that the one-part percutaneous entry needle malfunctioned, was defective, or not manufactured to specification.Monitoring will continue to be performed for similar complaints.
|