(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
The device was not returned for evaluation.
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 incidents from this lot.
The investigation determined the reported kink/bend and separation appear to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the reported difficulty positioning the balloon dilatation catheter.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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