BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure, the balloon was inflated at 6atm, 9atm respectively.However, the balloon ruptured upon third inflation at 12atm and was retrieved without problem.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Initial reporter city- (b)(6).
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure, the balloon was inflated at 6atm, 9atm respectively.However, the balloon ruptured upon third inflation at 12atm and was retrieved without problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that although there was resistance during removal, the balloon was just simply removed from the patient's body.The patient was good post procedure.
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