(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 prepped inside the anatomy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions 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 ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported balloon rupture.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 to treat a mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery.The 3.0x15mm nc trek balloon dilatation catheter (bdc) was soaked prior to use, however, it was not prepared (air aspirated) outside the anatomy.There was no resistance during advancement.The bdc was inflated once and the balloon ruptured at 18 atmospheres (atms).Another balloon was used to complete the procedure.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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