It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery.A 4.5 x 12 mm nc trek rx balloon dilatation catheter (bdc) was advanced for post-dilatation of a 4.0 x 26 mm unspecified drug-eluting stent and the balloon was inflated once to 14 atmospheres for 15 seconds.Although the balloon appeared to deflate angiographically without issue; the bdc could not be withdrawn into the guide catheter as it appeared to be too bulky [insufficient deflation].The bdc, wire, and guide catheter were removed as a single unit.An angiogram was performed to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual and functional inspections were performed on the returned device.The reported failure to fold the balloon and difficulty removing the device from the guiding catheter were confirmed; however, the reported deflation issue could not be confirmed.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 deflation issue; however, the reported failure to fold and difficulty removing the device appears to be related to operational context.Factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, a conclusive cause for the reported deflation issue could not be determined since the complaint could not be confirmed during return analysis.It is possible that as this is a high pressure balloon with a large diameter, the balloon profile is often not as small once the balloon has been inflated, and if the bdc was attempted to be retracted before it was completely deflated, it likely resulted in the proximal end of the balloon wrinkling/bunching and giving the appearance of being too bulky.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 noted wrinkled/bunched balloon contributed to the resistance met with the guiding catheter, resulting in the difficulty removing the bdc.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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