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 Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1 initial reporter address 1: (b)(6).
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Event Description
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It was reported that a balloon rupture occurred.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated at 6atm, however, it got ruptured at 4atm.The device was removed using normal method without any problem.The procedure was completed with another of same device.No complications were reported, and patient was good post procedure.
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Manufacturer Narrative
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E1 initial reporter address 1: (b)(6).
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Event Description
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It was reported that a balloon rupture occurred.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated at 6atm, however, it got ruptured at 4atm.The device was removed using normal method without any problem.The procedure was completed with another of same device.No complications were reported, and patient was good post procedure.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified distal right coronary artery.
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Search Alerts/Recalls
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