It was reported that while backloading the 3.0x15mm trek rx balloon dilatation catheter (bdc), over the 190cm whisper guide wire (gw), without resistance, and before entering the patient anatomy, the trek shaft broke, possibly at the hypotube, into 2 pieces.The device was removed from the guide wire without issue.There was no adverse patient effect and no clinically significant delay in the procedure.Another same size trek was used to complete the procedure.No additional information was provided.
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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/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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