The device 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 incidents reported from this lot.Factors that may contribute to difficulty removing the protective sheath may include, but not limited to, normal variation within the manufacturing process, protective sheath removal technique, damage during manufacturing, damage to the protective sheath, an undersized sheath and/or an oversized balloon profile and stent, mishandling or positive pressure applied during preparation.To ensure this type of issue is not the result of a manufacturing quality issue, all products are 100% visually inspected for damage.Additionally, a sampling of units is destructively tested to verify proper balloon/stent profiles.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the protective sheath.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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