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Model Number 20226 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.
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Manufacturer Narrative
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(e1) (b)(6).
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Event Description
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It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.
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Search Alerts/Recalls
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