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Model Number 24690 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
Event Type
malfunction
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Event Description
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It was reported that balloon pinhole occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery.A 5.0mmx30mmx135cm sterling balloon catheter was advanced for dilation.During the procedure, upon first inflation at 6 atmospheres for 10 seconds, the balloon could not stabilize the pressure, the fluid in the pressure pump was lost and blood appeared, and the balloon was not fully opened under digital subtraction angiography (dsa).The physician found that the balloon had a pinhole.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 15mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
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Event Description
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It was reported that balloon pinhole occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery.A 5.0mmx30mmx135cm sterling balloon catheter was advanced for dilation.During the procedure, upon first inflation at 6 atmospheres for 10 seconds, the balloon could not stabilize the pressure, the fluid in the pressure pump was lost and blood appeared, and the balloon was not fully opened under digital subtraction angiography (dsa).The physician found that the balloon had a pinhole.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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