As reported, the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured prior to reaching its nominal pressure.An hold nw 10/18 unknown 3mm x 100mm balloon catheter was then used and was successfully inflated.This was followed by the use of a 4mm x 20cm 155cm saberx pta balloon catheter which ruptured during an inflation between nominal pressure and 10 atmospheres (atm).As a result, a new unknown 4mm x 20cm balloon catheter was used in place of the 4mm x 20cm saberx pta balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) in which a contralateral cross-over approach was initially used.An unknown guidewire was inserted contralaterally; however, the wire went into the sub-lumen.Therefore, a retrograde approach was then made to continue the procedure.It was reported that during the use of the 4mm x 20cm saberx pta balloon catheter, ¿indentation¿ was not obtained due to a blockage caused by a calcified nodule.Additional information was requested but was not provided.The devices were discarded and will not be returned.
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This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05836.After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion:
as reported, the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured prior to reaching its nominal pressure.An unknown 3mm x 100mm balloon catheter was then used and was successfully inflated.This was followed using a 4mm x 20cm 155cm saberx pta balloon catheter which ruptured during an inflation between nominal pressure and 10 atmospheres (atm).As a result, a new unknown 4mm x 20cm balloon catheter was used in place of the 4mm x 20cm saberx pta balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) in which a contralateral cross-over approach was initially used.An unknown guidewire was inserted contralaterally; however, the wire went into the sub-lumen.Therefore, a retrograde approach was then made to continue the procedure.It was reported that during the use of the 4mm x 20cm saberx pta balloon catheter, ¿indentation¿ was not obtained due to a blockage caused by a calcified nodule.Additional information was requested but was not provided.(b)(4).The product was not returned for analysis.A product history record (phr) review of lot 82186298 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 devices were not returned for analysis.The exact causes could not be determined.Vessel characteristics of chronic total occlusion likely contributed to the reported event.A chronically occluded vessel makes crossing into the lesion difficult; damage to balloon material may have occurred in the attempt to cross or during inflation.However, without return of the products for analysis it is difficult to draw a clinical conclusion between the devices and 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 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.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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