(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 balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the violation of the ifu 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 during device preparation, the device was not soaked.During the coronary intervention, the nc trek balloon ruptured during the first inflation at 14 atmospheres.There was no adverse patient effect or a clinically significant delay in procedure.Another nc trek was used to complete the procedure.No additional information was provided.
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