As reported, an 8mm x 4cm 155 saber percutaneous transluminal angioplasty (pta) rapid exchange (rx) balloon catheter (bc) ruptured at approximately 4 atmospheres (atm) post dilation.Therefore, the device was removed intact in one piece from the patient and it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device prior to use.The device was prepped according to the ifu.The device was prepped normally (i.E.Maintain negative pressure).The target lesion was the iliac artery with 99% stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).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.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There were no guiding catheters used in the procedure.An ipsilateral approach was made from the femoral artery using a non-cordis sheath.Pre-dilation was performed with an unknown 6mm balloon catheter and a 12mm and 10mm smart stent was implanted.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was not ever in an acute bend.The maximum inflation pressure was between 3-5 atmospheres (atm).The balloon did not seem to ¿stick¿ to a stent.The device will not be returned for evaluation as it was discarded due to infectious disease.Additional procedural details were requested but are unknown.
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After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.An 8mm x 4cm x 155 saber percutaneous transluminal angioplasty (pta) rapid exchange (rx) balloon catheter (bc) ruptured at approximately four atmospheres (atm) post dilation.The target lesion was the iliac artery with(b)(4) stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).It was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.The device was stored and handled per the instruction for use (ifu).There was no damage noted to the packaging of the device prior to use.The device was prepped normally (i.E.Maintain negative pressure) according to the ifu.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There were no guiding catheters used in the procedure.An ipsilateral approach was made from the femoral artery using a non-cordis sheath.Pre-dilation was performed with an unknown 6mm balloon catheter and a 12mm and 10mm smart stent was implanted.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was not ever in an acute bend.The maximum inflation pressure was between three to five atmospheres (atm).The balloon did not seem to ¿stick¿ to a stent.The device was removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.The product was not returned for analysis as it was discarded due to infectious disease.A product history record (phr) review of lot 82168836 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 99% stenosis and procedural factors such as post-stent dilation may have contributed to the reported event.The stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent for post dilatation.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the 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 (b)(4) 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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