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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a heavily calcified, mildly tortuous, 90% stenosed lesion in the distal right coronary artery (drca).A 2x12mm mini trek balloon dilatation catheter (bdc) was advanced to the target lesion with resistance from the anatomy and inflated once to 10 atmospheres (atm) for 10 seconds when the balloon ruptured.The bdc was removed without issue.There was no adverse patient effect and no clinically significant delay in procedure.A 2x15mm non-abbott balloon catheter was used to successfully complete the procedure.No additional information was provided.
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