As reported, the balloon seemed to have a hole in it, which would not allow it to inflate to 15-atmosphre pressure (atm).After removing balloon from patient, the hole was identify.There was no reported patient injury.A new balloon was open and worked fine.The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device was prepped per the ifu.The device was prep normally.There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.The contrast to saline ratio was 10ml saline to 5ml contrast.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally as it was unable to inflate past 3-atmosphere pressure (atm) on first inflation.The maximum inflation pressure trying to get was 15 atm.The balloon did not maintain pressure during inflation.There were no kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.The balloon did not burst.The shaft did not burst.The product will be return for analysis.
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As reported, the balloon seemed to have a hole in it, which would not allow it to inflate to fifteen (15) atmosphere pressures (atm).After removing the balloon from patient, the hole was identify.A new balloon was open and worked fine.There was no reported patient injury.The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device was prepped per the ifu.The device was prep normally.There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.The contrast to saline ratio was 10ml saline 5ml contrast.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally as it was unable to inflate past three (3) atmosphere pressure (atm) on first inflation.The maximum inflation pressure trying to get was 15 atm.The balloon did not maintain pressure during inflation.There were no kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.The balloon did not burst.The shaft did not burst.One non-sterile unit of powerflex extreme 7x4 80cm was received coiled inside a plastic.Per visual analysis, it was noticed that the balloon was previously inflated and deflated.No other issues were found.Leak test was performed, and a leakage was found at the balloon¿s distal section near the distal seal area.The unit was sent to sem analysis to determine the cause of the leakage.Sem results showed that the leakage on the balloon was caused by a rupture of the balloon material near the balloon distal seal.The ruptured material presented evidence of elongations at the surrounding areas of material separation.The elongations observed suggest that the balloon material was induced to a tensile force that exceed the material yield strength prior to the material rupture.Cutting was discarded as root cause of the rupture.No other anomalies were found during the analysis.The unit was analyzed together with the product engineering team and it was found that the reported event was confirmed since a balloon leakage at distal section was caused by a rupture.Additionally, an assessment was performed by the product engineering team to identify a possible cause of the damage in the production line.After the assessment, it is concluded that the power flex extreme line include process controls to detect defects on the distal seal area or any leaks in all the catheter body.A device history record (dhr) review of lot 17730363 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was confirmed through analysis of the returned device due to the rupture found on the device.The root cause of this rupture could not be conclusively determined during the analysis.Based on the information available for review, vessel characteristics (although not provided) and handling factors may have contributed to the leakage/rupture found as evidenced by the elongations noted at the area of the material rupture.According to the ifu, which is not intended as a mitigation, ¿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.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.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.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
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