Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers, but neither were available.Csi also requested information regarding possible return of any of the devices, but information regarding availability of the devices was not available.If the devices do become available, they will be analyzed.The results of the investigation are inconclusive since the reported devices were not returned for analysis.Based on the information received, the cause of the reported events could not be conclusively determined.The device history record for the reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Date of event: date of article is 10 june 2020; however, csi is aware that the events occurred on or before 27 march 2019.(b)(4).The diamondback360® peripheral orbital atherectomy system instructions for use manual states that slow/no reflow is a potential adverse event that may occur with use of the system.Date received by manufacturer - due to an inadvertent delay in notification of the events within the article to postmarket surveillance, the mdr was not sent within 30 days of a csi employee becoming aware.Additional training was provided regarding csi's procedures for reporting complaints to postmarket surveillance.E.Ivan, b.Martinsen, z.Igyarto, et al., peripheral artery disease in vulnerable patient populations: outcomes of orbital atherectomy in native americans compared to non-native americans.A single center experience in rural oklahoma, cardiovascular revascularization medicine (2020), https://doi.Org/10.1016/j.Carrev.2020.06.008.(b)(4).
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