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 complaints appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a heavily tortuous, heavily calcified proximal right coronary artery.During advancement of the 3.75x8mm nc trek resistance was met with anatomy.Balloon dilatation was attempted; however, the balloon ruptured at the first inflation.Another unspecified balloon was used to complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
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