A visual, dimensional and functional inspection was performed on the returned balloon catheter.The reported difficulties were unable to be 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 and/or complaints reported from this lot.Factors that may contribute to difficulty inflating the device may include, but are not limited to, damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast dilution, inadequate connection to the inflation device, and/or accessory device support.To help ensure this difficulty is not related to a manufacturing issue, all balloon catheters are inspected/tested in manufacturing.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported difficult to advance, inflation problem and leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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