It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, and heavily calcified lesion in the mid left anterior descending artery.An unspecified stent was deployed.A 2.5x12mm nc trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was advanced to be used for post-dilation; however, resistance with the anatomy was felt.Once at the target lesion, the balloon ruptured at 12 atmospheres during the first inflation.The procedure was successfully completed with an unspecified 2.5x12mm bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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A visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 incidents from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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