A visual inspection was performed on the returned device.The reported device dislodged or dislocated and failure to advance were not tested due to the component not being returned.The reported material separation was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and device dislodged or dislocated are related to the operational context of the procedure.Additionally, the investigation was unable to determine a conclusive cause for the reported material separation.In this case, it is likely that the sds interacted with the heavily tortuous and heavily calcified anatomy, contributing to the noted twisted skive/wire/bayonet and ultimately resulting in the reported failure to advance and subsequent device dislodged or dislocated.Factors that could contribute to material separation include, but not limited to, patient disease state, anatomical morphology, user technique, and interaction with accessory devices.In this case, it is possible that the sds interacted with the challenging anatomy during retraction, contributing to the reported material separation; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1 - adverse event/product problem "adverse event" was removed.B2 - outcomes attributed to ae "other serious" was removed and replaced with "na".H1 - type of reportable event updated from "serious injury" to "malfunction".H6 - health effect - clinical code 2687 was removed and 4582 added.H6 - health effect - impact code 2199 added.
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