BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7163 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was good.
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Manufacturer Narrative
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Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.There was a 14mm longitudinal tear, 8mm from the tip and the tip of the device was damaged.Product analysis confirmed the reported event, as the device was found to have a longitudinal tear to the balloon.
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was good.
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