The device was not returned for evaluation.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 complaints.Based on the information provided, a definitive cause for the tip detachment could not be determined.It may be possible that the tip was not retracted and locked in place prior to removal causing interaction with the stent or anatomy resulting in separation; however, this could not be confirmed.The additional treatment to snare the detached tip was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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