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Catalog Number 51005030L |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, the balloon of a 5mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to 8 atmospheres (atm).As a result, the 5mm x 30cm 155cm saberx pta balloon catheter was removed and another 5mm x 30cm 155cm saberx pta balloon catheter was inserted and successfully inflated.An unknown stent was implanted, and the procedure was completed without injury to the patient.The target lesion was the superficial femoral artery (sfa) which had a stenosis and mild calcification.An unknown.018 guidewire was inserted followed by an intravascular ultrasound (ivus) catheter and an ivus procedure was performed.The saberx pta was then inserted and inflated to 8 atm when it ruptured.The saberx pta was prepared with a 50/50 contrast-saline mixture.Additional information was requested but was not available, and the device was discarded and will not be returned for evaluation.
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Manufacturer Narrative
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As reported, the balloon of a 5mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to eight atmospheres (atm).As a result, the 5mm x 30cm 155cm saberx pta balloon catheter was removed and another 5mm x 30cm 155cm saberx pta balloon catheter was inserted and successfully inflated.An unknown stent was implanted, and the procedure was completed without injury to the patient.The target lesion was the superficial femoral artery (sfa) which had a stenosis and mild calcification.An unknown.018 guidewire was inserted followed by an intravascular ultrasound (ivus) catheter and an ivus procedure was performed.The saberx pta was then inserted and inflated to eight atm when it ruptured.The saberx pta was prepared with a 50/50 contrast-saline mixture.Additional information was requested but was not available.The device was not returned for evaluation as the device was discarded.A product history record (phr) review of lot 82222040 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 stenosis and mild calcification likely contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and 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 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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Search Alerts/Recalls
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