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 11/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that a balloon ruptured.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was no problem in crossing the lesion, but when pressure was applied up to 8 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Based on the potential root causes identified in the fmea and the complaint report, the following attributes were examined: a visual examination identified that the balloon wings were in a deflated state and had been subjected to positive pressure.A microscopic examination of the balloon found no tears or holes in the balloon material.The device was attached to a boston scientific encore inflation unit and during an attempt to inflate the balloon a pinhole leak confirmed.The pinhole leak was confirmed in the distal transition zone in the balloon.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 found no kinks along the length of the hypotube.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.
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Event Description
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It was reported that a balloon ruptured.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was no problem in crossing the lesion, but when pressure was applied up to 8 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No complications reported.
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Search Alerts/Recalls
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