Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.One used decontaminated sample was returned for investigation without its original packaging.During visual inspection, it was noticed that inflation line was detached from pilot balloon.A product sample was received for evaluation.The returned sample was visually inspected under normal conditions of illumination according to procedure.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus, the failure mode reported is confirmed.A non-conformance report was created to perform a complete cause analysis for the failure mode reported for inflation line detached.The analysis performed in the sample received concluded that although some gaps detected on the maintenance equipment during the investigation this is a minor factor; the cause of this failure condition could be caused due to lack of solvent adherence per material properties.Also, during the non-conformance report actions were implemented to mitigate this reported condition by improving process steps directly related with factors in the process that may infer on this failure: a checklist to the procedure that is used to release the equipment, will include a verification in the critical alignment tooling that technician needs to do, with the purpose to confirm that tube can be inserted properly and the connection with the balloon is secure, avoiding weak joint between these two components.Also, updating the maintenance procedure to record preventive maintenance to include a new method of the maintenance execution verification in order to assure adherence to the procedure and that samples produced after maintenance keeps the quality features consistently.
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