As reported, a 2mm x 10cm 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was inserted, however; pressure could not be applied during its initial inflation.Therefore, it was replaced with the same size saber rx pta balloon catheter, but the same issue had occurred.Therefore, it was replaced with a new non-cordis balloon catheter and it could be inflated.There was no reported patient injury.The target lesion was the popliteal artery which had a chronic total occlusion (cto).A contralateral approach was made.A 55cm non-cordis guiding catheter was used.A non-cordis guidewire was inserted.The devices will be returned for evaluation.Addendum: product evaluation on 06-jul-2020 revealed that both reported devices were returned with their balloons were ruptured.
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After further review of additional information received the following sections have been updated accordingly: d4, g3, g4, g6, h1, h2, h3, h6, and h10.This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05893.Complaint conclusion: as reported, a 2mm x 10cm 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was inserted, however; pressure could not be applied during its initial inflation.Therefore, it was replaced with the same size saber rx pta balloon catheter, but the same issue had occurred.Therefore, it was replaced with a new non-cordis balloon catheter, and it could be inflated.There was no reported patient injury.The target lesion was the popliteal artery which had a chronic total occlusion (cto).A contralateral approach was made.A 55cm non-cordis guiding catheter was used.A non-cordis guidewire was inserted.The product was returned for analysis.A non-sterile unit of a saber rx 2mm10cm155 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.Blood residues were observed inside both the balloon and the body/shaft catheter.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed on the body/shaft transition to balloon area.Per sem analysis on the unit¿s leakage observed during inflation test, results showed that the balloon burst was caused by a rupture on the body/shaft transition to balloon area.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of bulged/peeled off material and scratch marks near the body/shaft transition to balloon area rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed bulged/peeled off material and scratch marks on the body/shaft transition to balloon area surface could have led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82184769 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - unable to inflate¿ and subsequent findings of ¿balloon burst¿ were confirmed via device analysis as a leakage was noted during functional analysis for both devices.However, the exact cause cannot be determined.The first balloon analyzed showed the outer surface presented evidence of bulged/peeled off material and scratch marks near the body/shaft transition of the balloon, the second analyzed balloon noted a rupture to the proximal area of the balloon.The outer surfaces of the balloon material presented evidence of scratch marks adjacent to the ruptures noted.It is likely vessel characteristics of a chronic total occlusion contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.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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