The events are part of a retrospective study.Vessel perforation requiring intervention is captured (see attached).As the lot numbers for the devices were not provided, a manufacturing review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported events is inconclusive.Based upon the available information, the definitive root cause for these events is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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