(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.
The reported separation was confirmed; however, the difficulty to position of the guide wire could not be confirmed.
In this case, a conclusive cause for the reported difficulty could not be determined as the reported complaint could not be confirmed during return analysis.
Additionally, it was reported that the shaft separated due to the attempts to load the device onto the guide wire against resistance.
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
Additionally, a review of the complaint history identified no other similar incidents from this lot.
The investigation was unable to determine a conclusive cause for the reported difficulty to position of the guide wire; however, the shaft separation appears 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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