As reported, the 6mm 6cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inflated at the lesion but it ruptured at 3 atmosphere (atm).The device was replaced with another unknown balloon catheter and the procedure continued.There was no reported patient injury.The target lesion was located at the right superficial femoral artery (sfa).The lesion has 0% calcification but, has little vessel tortuosity with 75% of stenosis noted.The device was not used for a chronic total occlusion.The device was stored, handled and prep per the instructions for use (ifu).The device was prep normally.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop as well as at the protective balloon cover.There was no kinked or other damaged noted prior to inserting the product into the patient.A non-cordis contrast media was used with 1:1 ratio of contrast to saline.The indeflator used was a non-cordis indeflator and was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter.The catheter was never bent.There was no difficulty experienced upon crossing the lesion and no usual forced was applied at any time during the procedure.The product was removed intact in one piece from the patient.The device will not be returned for evaluation as it was discarded.
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After further review of additional information received the following sections g4, g7, h2 and h6 have been updated accordingly.The 6mm x 6cm x 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inflated at the lesion but it ruptured at three atmospheres (atm).There was no reported patient injury.The target lesion was located at the right superficial femoral artery (sfa).The lesion no calcification but, had little vessel tortuosity with (b)(4) stenosis.The device was not used for a chronic total occlusion.The device was replaced with another unknown balloon catheter and the procedure continued.The device was stored, handled and prepped normally per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.Non-cordis contrast media was used with a 1:1 ratio of contrast to saline.A non-cordis indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The catheter was never bent.There was no difficulty experienced upon crossing the lesion and no usual forced was applied at any time during the procedure.The product was removed intact in one piece from the patient.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17672693 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of stenosis may have contributed to the reported event.However, based on the information available for review and without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.According to the warnings in the safety information in 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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
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