It was reported that the procedure was performed to treat a lesion in the heavily calcified, 90% stenosed right coronary artery.A 5x12mm nc trek balloon dilatation catheter (bdc) was advanced without resistance.After inflation at 14 atmospheres, the balloon would only partially deflate.The bdc was being removed but faced resistance with an unspecified guiding catheter, so force was applied.The shaft of the bdc separated in the guiding catheter, so everything was removed together.No portion of the device remains in the anatomy, and an unspecified nc trek was used to successfully 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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The device was returned for analysis.The reported difficult to remove and the reported material separation were able to be confirmed.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after inflation at 14 atmospheres manipulation of the device and/or an sufficient amount of time was not allowed to fully deflate the balloon resulting in the noted multiple stretches to the outer member; thereby reducing the inflation/deflation lumen thus resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device using force resulted in the noted device damages (separated inner member, torn outer member) and ultimately resulted in the reported material separation.The noted multiple bends and kinks on the hypotube likely occurred due to handling or during packing for return analysis.Reportedly, the balloon dilatation catheter (bdc) was being removed but faced resistance with an unspecified guiding catheter, so force was applied.The shaft of the bdc separated in the guiding catheter, so everything was removed together.It should be noted that the nc trek rx coronary dilatation catheter instructions for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.Additionally, it should be noted that the nc trek rx coronary dilatation catheter instructions 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.Although it was noted that resistance was noted during withdrawal, this was due to resistance with the guiding catheter therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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