(b)(4).
Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.
The reported separation and kink were confirmed.
The reported difficulty to position over the guide wire was not confirmed.
A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.
Additionally, a review of the complaint history identified no other similar incidents from this lot.
The investigation determined the reported shaft separation, kink and difficulty positioning the device with the guide wire appear to be related to circumstances of the procedure.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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