(b)(4).The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
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It was reported that the procedure was to treat a lesion located in the moderately tortuous, heavily calcified, 75% stenosed distal right coronary artery.After a guide wire crossed the lesion, the 2.5 x 20 mm trek rx balloon catheter was advanced for pre-dilatation.The balloon was inflated to 8 atmospheres, one time, when it ruptured.Resistance was felt during advancement of the balloon catheter to the lesion.A new trek rx balloon catheter was used to complete the procedure.No adverse patient effects or clinically significant delay in the procedure were reported.
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