Model Number 7590 |
Device Problems
Material Rupture (1546); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, on the second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.There were no pieces left in the patient's body.The device was also noted to be kinked due to angulation when crossing the lesion.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 25mm from the tip of the device.The device failed to inflate to rated burst pressure.Product analysis confirmed the reported events, as during functional testing the device was found to have a pinhole damage to the balloon and there were numerous kinks to the hypotube of the device.
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, on the second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.There were no pieces left in the patient's body.The device was also noted to be kinked due to angulation when crossing the lesion.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Search Alerts/Recalls
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