Evaluation by manufacturer: the returned product that was received by boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually and microscopically inspected for damage.There was blood in the device.The device showed 2 buckling/kinks on the shaft located 1cm, and 129.3cm from the tip.The device was attempted to be connected to the console per the ifu.The jetstream connector did not connect to the console.Analysis of the connector showed bent pins.Functional analysis of the device could not be completed due to the bent pin damage.A.014 guidewire was inserted into the device and the wire transcended through the device with a restriction due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint for a bubble error was not confirmed; however, shaft damage and bent pins in the connector were confirmed.
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