Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer 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.However, the user facility provided a picture.From the picture, the actual device seemed to have been inserted in the holder.It was impossible to confirm the state of the distal tip section.The wire clip was found attached to the holder.Reproductive testing was performed, referring to the state of the actual sample in the provided picture, about 50 mm from the distal end of a guidewire sample was pinched firmly, and then pulled from the holder, while the wire clip was still attached to the holder.As a result, the urethane coating of distal 50 mm was peeled off.Regarding the involved product code/november 2020 production lot (0yk), review of the manufacturing record and product-release judgement record confirmed no anomaly recorded in them.It is likely that the urethane coating was peeled off 50 mm from the distal end due to an excessive tensile load having been applied to the actual sample during removal from the holder.In addition, a reproductive test showed that there was a possibility that a tensile load could have been applied to the guidewire when the guidewire was pulled from the holder while the wire clip was attached to the holder.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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