Date of event estimated.The udi number is unknown as the catalog number and lot number were not provided.The device was not returned for analysis.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.It is possible that during guide wire removal the seal was not fully opened resulting in the reported difficult to remove; however, as the device was not returned for analysis the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|