BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The 94% stenosed, 10mmx3.0mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon delivery shaft was fractured.The device was completely removed as usual from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient is stable.
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Event Description
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It was reported that shaft break occurred.The 94% stenosed, 10mmx3.0mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon delivery shaft was fractured.The device was completely removed as usual from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient is stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was in a deflated state.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination of the hypotube identified multiple kinks along its length.There were no breaks in the hypotube.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.
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