The device was not returned for evaluation.The electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported difficulties could not be determined.Factors that could contribute to material deformation include, but are not limited to, damage during manufacturing, inadvertent mishandling during sheath/stylet removal, unpackaging, preparation, or during use of the device, interaction with accessory devices, patient anatomical morphology, or patient disease state.Factors that may contribute to an activation failure including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that a loose connection with the indeflator may have contributed to the reported activation failure including expansion failures.Further interaction with the moderately calcified, moderately tortuous anatomy may have contributed to the reported material deformation; however, this cannot be confirmed.Based on the information provided and without the device to examine, a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
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