Visual inspection was performed on the returned device.The reported separation was confirmed.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 and/or complaints from this lot.The investigation determined the reported separation appears 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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It was reported that the procedure was to treat an unspecified lesion.While advancing the 3.75x12mm nc trek balloon dilatation catheter (bdc) through the guiding catheter, the proximal shaft of the bdc separated into two pieces.The separation occurred outside of the patient's anatomy; therefore, the separated pieces were simply removed.The guiding catheter remained in the patient and a new unspecified bdc was used to 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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