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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified, moderately tortuous and 90% stenosed artery causing the reported failure to advance and subsequent deformation due to compressive stress (tip kink).During removal resistance was once again felt due to the difficult anatomy causing the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 90% stenosed lesion in the mid right coronary artery (mrca).A 3.5x12mm nc trek balloon dilatation catheter (bdc) was advanced with resistance and could not cross the anatomy to reach the target lesion.The bdc was removed with resistance from the anatomy, and it was noted that the tip was deformed.Another trek bdc was used with an extension catheter to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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