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 indication of a lot specific product quality issue.Based on the information provided, the difficulty removing, and subsequent stretched tip coils and break were likely due to circumstances of the procedure.In this case, it is likely that clearance between the inner diameter of the jetstream device and outer diameter of the barewire became reduced during use resulting in the devices becoming stuck together causing difficulty to remove, and the reported damage to the tip coils.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 atherectomy procedure was to treat a mildly tortuous, heavily calcified distal femoral popliteal segment.The emboshield nav6 barewire was exchanged for a longer barewire to be used.The barewire was advanced to the target lesion and the procedure was completed.At the end of the procedure, when a non-abbott atherectomy device was being removed, it met resistance with the barewire.Once the barewire was removed, it was noted to be damaged badly at the distal end (unraveled, stretched).It was confirmed there were no issues with the use of the emboshield nav6 device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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