The device was not returned 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 and/or complaints reported from this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that during advancement the balloon became compromised and/or damaged against the heavily calcified anatomy and/or other devices used in the procedure resulting in the reported balloon rupture; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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