Investigation - evaluation: a review of device history record, drawing, specification, complaint history, instructions for use (ifu), quality control and visual inspections was conducted during on the returned product during the investigation.The customer reported that the microcatheter was fractured near the hub prior to use.Visual inspection showed that the catheter itself was actually kinked under the strain relief.A review of the complaint history revealed there were no related complaints.The device history record showed no nonconformances were reported related to the failure mode.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number 7788485.The risk specification document was reviewed for potential failure modes, causes and effects of failure, and current controls in place to mitigate the occurrence.One potential failure mode is kinking of the catheter shaft.The manufacturing process checks for any defects, so the damage may have occurred during shipping/packing or device preparation.Therefore, the root cause was determined to be inconclusive since there was no evidence to suggest the kink in the tubing occurred during shipping/packaging or device preparation.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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