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
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device would not inflate.During the procedure, it was not possible to inflate the balloon.The device was replaced to complete the procedure.There were no patient injuries reported.However, the return device analysis revealed a pinhole leak in the device.
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Manufacturer Narrative
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Device evaluated by manufacturer: a wolverine cb mr, ous 10mmx3.00mm was returned for analysis.A visual and microscopic examination of the balloon identified no tears or holes in the balloon material.The device was attached to an encore inflation and during an initial attempt to inflate the balloon, a pinhole leak was identified in the balloon material.The pinhole was located just distal to the proximal marker band.No issues were identified with the balloon which could have contributed to the pinhole leak.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination of the hypotube/shaft found no kinks or damages.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands which could potentially have contributed to the pinhole leak.
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