CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 4401004X |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint conclusion: a powerflex pro balloon catheter (10mm x 4cm x 135cm) was delivered to the lesion in the left subclavian vein and inflated; however, the device ruptured at 6 atmospheres (atms) during its second inflation.The lesion was described as having repeated severe stenosis.There was no patient injury reported.The device was replaced with a non-cordis balloon catheter of the same size to complete the procedure.Initially, an approach was made from the femoral artery using a non-cordis guiding sheath, a non-cordis guidewire crossed the lesion and a non-cordis balloon catheter was used for initial dilation.The product was not returned for analysis.A product history record (phr) review of lot 17738464 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 severe stenosis may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a severely stenosed vessel.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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Event Description
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As reported, a powerflex pro balloon catheter (10mm4cm 135) was delivered to the lesion in the left subclavian vein and inflated, however, the device ruptured at 6 atmospheres (atms) during its second inflation.The device was replaced with a non-cordis balloon catheter of the same size to complete the procedure.Initially, an approach was made from the femoral artery using a non-cordis guiding sheath, a non-cordis guidewire crossed the lesion and a non-corids balloon catheter was used for initial dilation.The kesion was described as having repeated severe stenosis.There was no patient injury reported.The device was clinically used and has been discarded, so will not be returned for analysis.
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Search Alerts/Recalls
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