It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 75% stenosed lesion in the mid left anterior descending (mlad) artery.Post-dilatation was being performed with a 2.5x15mm nc traveler balloon dilatation catheter (bdc) when the contrast agent was noted as leaking under imaging and the pressure did not increase.It was suspected that a balloon rupture occurred on the first inflation to 12 atmospheres (atm).The bdc was removed, and another balloon was used to complete post-dilatation and successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.
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