BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/04/2020 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No known patient complications nor injuries reported.
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Event Description
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It was reported that balloon rupture occurred.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No known patient complications nor injuries reported.It was further reported that the 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.The balloon ruptured during third inflation at 12 atmospheres for 5 seconds.There were no patient complications nor injuries reported and the patient's status was fine.
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