Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k062858, k082644.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the shipping inspection record.Ifu states: do not scratch the sheath with needle point, cutting tool, or other edged tools.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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The user facility reported that while the professor was retrieving the actual radifocus introducer ii h, after a pta surgery, the sheath's distal tip fractured about 2.5 cm, and it remained in the pulmonary artery.The doctor tried to extract the fractured segment from the patient; however, failed.
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