BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 3822 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 05/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred and the patient was sent for surgery.The calcified target lesion was located in the proximal and mid left circumflex artery.A 10/2.75 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that balloon burst at 5 atm.The patient was sent for surgery.No further patient complications were reported.
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Event Description
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It was reported that a balloon rupture occurred and the patient was sent for surgery.The calcified target lesion was located in the proximal and mid left circumflex artery.A 10/2.75 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that balloon burst at 5atm.The patient was sent for surgery.No further patient complications were reported.It was further reported that the proximal and mid left circumflex artery was moderately calcified.The device was completely removed from the patient without intervention.The patient was stable.
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