The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to insert and the reported deformation due to compressive stress were unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.Further manipulation resulted in the noted stretched tip and ultimately resulted in the reported tip separation; thus resulting in the reported difficulty to insert.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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