The clarivein device was not available for investigation.There were no issues cited with device performance.No additional information or documentation was provided.Out of an abundance of caution vascular insights has decided to file an mdr within the specified 30 day reporting period potential adverse effects that might be associated with the clarivein® device are similar to those associated with any interventional vascular procedure.The ifu provided with the clarivein device lists the potential adverse events that might be encountered during a peripheral vasculature infusion procedure using the clarivein® ic as well as instructs the user to consult labeling of agents to be delivered prior to infusion.
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