After further review of additional information received the following sections have been updated accordingly: b3, g3, g4, g6, h1, h2, h3, h6, and h10 complaint conclusion: the balloon of a 4mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to nominal pressure.There was no reported injury to the patient.This was during an interventional procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa).Additional information was requested but was not provided.The product was not returned for analysis.A product history record (phr) review of lot 82215054 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.Procedural or handling factors may have contributed to the reported event.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 (b)(4) of the balloons (with a (b)(4) 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 (b)(4) mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr review nor the very limited information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
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