Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Date of event: requested, not provided.Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the shipping inspection record of the product code/lot# combination was unable to be conducted due to the unknown lot number.The same user facility reported similar events.This report is for the second device, see mdrs: 9681834-2017-00272 and 9681834-2017-00274 for the first and third device.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.Ifu for this product has the instructions as follows: advance or withdraw the mini guide wire slowly.If resistance is met, do not advance or withdraw the mini guide wire until the cause of resistance is determined.(b)(4).
|