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 other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported winged balloon; however, the reported difficulty removing the device appears to be related to operational context.Factors that may contribute to a non-uniform balloon refold (winged balloon) include, but not limited to, large balloon profile, deflation technique and multiple inflations.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.Choosing a larger guiding catheter size may minimize this.In this case, it is possible that the combination of the larger profile of the 4.50 mm balloon and the reported winged balloon contributed to the resistance met with the guiding catheter, resulting in the difficulty removing the balloon dilatation catheter.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a moderately calcified, non-tortuous right coronary artery.After use of the 4.50x8mm nc trek balloon dilatation catheter, the balloon fully deflated but the balloon wings did not refold properly.The catheter then got stuck with the 6f guiding catheter during the attempted removal and the two devices had to be removed together as a single unit.The procedure was complete at that point; therefore, no further action was needed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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