It was reported that the procedure was to treat a lesion in the second obtuse marginal (om) artery with mild calcification and mild tortuosity.The 4.0x15mm nc trek balloon dilatation catheter (bdc) was used for post dilatation and was inflated once at 12 atmospheres (atms).Negative was held for approximately 5 seconds or more, however, the balloon failed to deflate and was withdrawn partially inflated.There was no difficulty removing the stylet or protective sheath.The device was not prepared (air aspiration) outside the anatomy prior to use.The contrast mix was unknown.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).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.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the violations of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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