It was reported that during the procedure, the dragonfly optis imaging catheter was to be used in the left main coronary artery (lm) and the left anterior descending (lad) artery.The device was pulled back into the catheter; however, the distal end of the device was stuck on the balanced middle weight (bmw) guide wire (gw), and the guide wire felt sticky when removing.There was no device separation or other damage noted.The devices were removed as a single unit.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
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Visual and dimensional analysis was performed on the returned device.The reported difficulty removing the catheter was unable to be confirmed.Lot history record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The investigation determined that the difficulties were likely related to circumstances of the procedure.The distal end of the guidewire exit notch was noted to be stretched, which suggests that either positioning or withdrawal difficulty were encountered during use but cannot be directly attributed as the cause for the difficulty to remove.There were no damages nor anomalies to the catheter which could be directly attributed to reported difficulty to remove.Based on the reported information of the guidewire feeling sticky during attempted withdrawal and the lack of catheter anomalies, it is likely that the difficulty removing the catheter was caused by operational context/patient anatomical conditions (contamination on guidewire, guidewire damage, heavy calcification, etc).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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