(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported cracked hub and reported leak were confirmed.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during preparation, the inflation device was over torqued during connection to the hub resulting in the reported cracked hub; thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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