The sections have been updated.As reported, a saber rx 8 mm x 40 mm 155, used for post dilatation after stent deployment, was caught by the stent and ruptured.It is unknown how the procedure was completed; however, it was reported that the procedure was completed successfully.There was no reported patient injury.The target lesion was the superficial femoral artery.The patient¿s information, vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % chronic total occlusion cto).Multiple attempts were made without success to obtain additional information.The product was clinically used and it will not be returned for analysis.A device history record (dhr) review of lot 17449264 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported balloon burst could not be confirmed without the return of the device for analysis per the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ the dhr review did not reveal any issues that could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
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