Estimated date of event.Unique device identifier (udi): the udi is not available because the part number and lot number were not provided.Exemption number e2019001.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported failure to fold; however, factors that could contribute to failure to fold include, but are not limited to, inadequate time allowed for balloon deflation and balloon material.The reported failure to advance and difficulty to remove appear to be related to operational context of the procedure as it is likely the reported incomplete balloon refold interacted with the lesion causing the reported failure to advance.The device interacted with the guiding catheter during removal causing the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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