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
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
Injury
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Event Description
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It was reported that the shaft got fractured.The 56mm x 3.0mm in diameter, 70% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery (lcx).A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured.Another balloon was used to hold down the fractured shaft and pull out the device.The procedure was completed with another of same device.There were no patient complications reported, and patient was stable post procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no damages.A hypotube break was identified, 75.9cm distal to the distal end of the strain relief and multiple hypotube kinks were noted along the shaft of the device.No kinks or damages on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.The proximal and distal markerbands identified no damage.
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Event Description
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It was reported that the shaft got fractured.The 56mm x 3.0mm in diameter, 70% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery (lcx).A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured.Another balloon was used to hold down the fractured shaft and pull out the device.The procedure was completed with another of same device.There were no patient complications reported, and patient was stable post procedure.
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