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 12/14/2023 |
Event Type
malfunction
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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, at first inflation, it was noted that the balloon ruptured at 6atm within 5 seconds.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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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, at first inflation, it was noted that the balloon ruptured at 6atm within 5 seconds.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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