(b)(4).The product was not returned to abbott vascular for analysis.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to position the guide wire/sheath and difficulty removing the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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