The lesion was severely calcified, with 70 percent stenosis, and no tortuosity.The device was not used for a chronic total occlusion (cto).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter was removed easily and intact from the patient.As reported, a 6x20mm 80cm powerflex pro percutaneous transluminal angioplasty (pta) catheter was inflated and ruptured at ten atmospheres (10 atm).It was then replaced with a same size non-cordis balloon catheter (bc) and inflated at fifteen atmospheres (15 atm) to complete the procedure.No patient injury was reported.The lesion was the superficial femoral artery (sfa) with severe calcification, had 70% rate of stenosis, and no tortuosity.The device was not used for a chronic total occlusion (cto).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.After the balloon ruptured, the balloon catheter was removed easily and intact from the patient.Additional procedure details were requested but are unknown.The device was not returned for analysis due to the patient having suspicious infectious disease.A device history record (dhr) review of lot 17633516 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (severe calcification with 70% stenosis) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.
|