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Model Number 51004030L |
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 02/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the manufacturing documentation associated with lot 82222004 presented no issues during the manufacturing process that can be related to the reported event.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 saber rx 4mm 30cm 155 ruptured during pre-dilation in the left superficial femoral artery; however, the balloon was inflated to 5atm and ruptured.The case was completed after the use of a another balloon catheter (unknown).There was no reported injury to the patient.The lesion was noted to have a chronic total occlusion (cto).The device will not be returned for evaluation as it was discarded.
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Manufacturer Narrative
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As reported, the balloon of a saber rx 4mm 30cm 155 ruptured during pre-dilation in the left superficial femoral artery.The balloon was inflated to five atm and ruptured.The case was completed after the use of another balloon catheter (unknown).There was no reported injury to the patient.The lesion was noted to have a chronic total occlusion (cto).The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82222004 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿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 chronic total occlusion likely contributed to the reported event.A chronically occluded vessel makes crossing into the lesion challenging; it is likely damage to balloon material occurred in the attempt to cross or upon inflation.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device 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.(b)(4).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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Event Description
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As reported, the balloon of a saber rx 4mm 30cm 155 ruptured during pre-dilation in the left superficial femoral artery; however, the balloon was inflated to 5atm and ruptured.The case was completed after the use of a another balloon catheter (unknown).There was no reported injury to the patient.The lesion was noted to have a chronic total occlusion (cto).The device will not be returned for evaluation as it was discarded.
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Search Alerts/Recalls
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