A visual and dimensional inspection was performed on the returned balloon catheter.The reported difficulty to remove the protective sheath was unable to be confirmed since the protective sheath was not returned on the balloon.The reported proximal shaft separation was not confirmed as there were no separations noted on the device.There was no damage observed to the 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 and/or complaints 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, mishandling or positive pressure applied during preparation.Design and manufacturing controls have been established to mitigate possible causes.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the protective sheath and proximal shaft separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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