It was reported the turntrac and optical coherence tomography (oct) dragonfly opstar imaging catheter were delivered without any problems distal into the left anterior descending (lad) lesion.However, after the third successful image, removal of the dragonfly catheter was not possible, it was stuck with the turntrac guidewire.Both the turntrac and the dragonfly were removed together.The turntrac was inspected outside the patient anatomy, and it was observed that the distal tip of the turntrac was broken and it seems like the coils are not in the correct position.The turntrac was stuck in the oct dragonfly catheter.There were no adverse patient effects and no clinically significant delay.No additional information was provided.
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Visual analysis was performed on the returned devices.The reported difficulty removing was confirmed as the devices were returned frozen together.The lot history record (lhr) 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.Based on the information provided and evaluation of the returned devices, the difficulty removing was likely due to the damage noted on the distal portion of the turntrac guide wire.The noted bends and misaligned coils likely impacted the clearance between the guide wire and dragonfly catheter causing the devices to become stuck together and prevented the ability to remove the dragonfly catheter from the wire.Although a definitive cause for the guide wire damage could not be determined, this type of damage is consistent with interaction between the guide wire and the anatomy and/or associated devices during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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