BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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B3 date of event was estimated based on report of "pci was performed for the lesion in may x." "mp67-4_a case of wolverine cutting balloon blade dropout," was on a poster presentation at a conference on complications, (b)(6) 2023 in (b)(6) japan.
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Event Description
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It was reported that removal difficulty and a blade detachment occurred.The patient presented with chest tightness suggesting ischemic complications.Coronary angiography revealed a 99% stenosed target lesion located in the severely calcified right coronary artery.The lesion was prepared via rotablation with a 1.75 mm burr and successfully dilated with a 3.25 mm wolverine cutting balloon.However, upon removal of the balloon, resistance was encountered, and a blade detached likely due to the severe calcification of the lesion.Intravascular ultrasound (ivus) confirmed a residual object thought to be the blade.
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Manufacturer Narrative
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B3 date of event was estimated based on report of "pci was performed for the lesion in may x."."mp67-4_a case of wolverine cutting balloon blade dropout," was on a poster presentation at a conference on complications, saturday, (b)(6) 2023 in (b)(6).
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Event Description
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It was reported that removal difficulty and a blade detachment occurred.The patient presented with chest tightness suggesting ischemic complications.Coronary angiography revealed a 99% stenosed target lesion located in the severely calcified right coronary artery.The lesion was prepared via rotablation with a 1.75 mm burr and successfully dilated with a 3.25 mm wolverine cutting balloon.However, upon removal of the balloon, resistance was encountered, and a blade detached likely due to the severe calcification of the lesion.Intravascular ultrasound (ivus) confirmed a residual object thought to be the blade.
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Search Alerts/Recalls
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