As reported, a saber pta balloon catheter, the marker on the proximal end of the balloon appears to be mis-aligned.¿there was no harm came to the patient but it did cause a concern during the case." there was no reported patient injury.The target lesion was the left-superficial femoral artery (sfa).The vessel level of calcification is none.The vessel level of tortuosity is mild.The vessel level of stenosis is 70%.The device was not used for chronic total occlusion (cto) lesion.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was prepped properly according to the ifu.The device was prep normally.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoro throughout the procedure but there was panning up and down due to the length of the vessel.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.Not all marker bands were accounted after the catheter was removed from the patient.There was no kink/bend noted in the area of separation.The devices will be returned for analysis.
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As reported, a 5x300mm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the marker on the proximal end of the balloon appears to be mis-aligned.¿there was no harm came to the patient, but it did cause a concern during the case." there was no reported patient injury.The target lesion was the left-superficial femoral artery (sfa).The vessel level of calcification is none.The vessel level of tortuosity is mild.The vessel level of stenosis is 70%.The device was not used for chronic total occlusion (cto) lesion.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was prepped properly according to the ifu.The device was prep normally.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoroscopy throughout the procedure but there was panning up and down due to the length of the vessel.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.Not all marker bands were accounted after the catheter was removed from the patient.There was no kink/bend noted in an area of separation.A non-sterile saber 5mm30cm 150 was received coiled inside a plastic bag.Balloon was already inflated.No damages or anomalies were observed.Dimensional analysis was performed to verify the correct distance between the distal and proximal marker band.Measurement was compared against the specification and the result was found within specification.A device history record (dhr) review of lot 17711129 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band offset/out of position¿ was not confirmed since the marker bands were found to be within specification.The exact cause of the issue experienced could not be conclusively determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the instructions for use, which is not intended as a mitigation, ¿radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ neither the dhr review, nor the product analysis suggests that the reported issue could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.
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