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
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Event Description
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It was reported that the balloon was torn.The 50% stenosed target lesion was located in the middle to distal left anterior descending artery (lad).A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During preparation, when the air in the balloon was removed outside the patient, the balloon was torn or had a hole, so the air had come out.The procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic, and leakage analysis were performed on the device.A visual and tactile examination identified no damages hypotube shaft profile and shaft polymer extrusion.A visual examination identified some traces of blood inside the balloon.A detailed microscopic examination of the balloon material identified no tears or damages.All blades were fully bonded onto the balloon.A microscopic examination of the tip section and proximal markerband found no damages.The device was attached to an encore inflation unit and liquid leaked out through a pinhole leak.The pinhole leak was noted over the proximal markerband.
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Event Description
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It was reported that the balloon was torn.The 50% stenosed target lesion was located in the middle to distal left anterior descending artery (lad).A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During preparation, when the air in the balloon was removed outside the patient, the balloon was torn or had a hole, so the air had come out.The procedure was completed with another of the same device.There were no patient complications reported.
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Search Alerts/Recalls
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