(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 should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu) (preparation for use section) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined the reported complaints appear to be related to operational context.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 the heavily calcified, mildly tortuous left main coronary artery (lmca).Prior to use, the 3.5x15 mm trek balloon dilatation catheter (bdc) was not soaked in saline and was advanced with resistance noted with the anatomy.The bdc was intended to be used for pre-dilatation; however, the balloon ruptured on the first inflation at 15 atmospheres (atm) due to the calcification.A non-abbott balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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