BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 43.1cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink.
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Event Description
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Reportable based on device analysis completed on 28jan2021.It was reported that shaft kink occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left coronary artery (lca).A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation; however, the delivery shaft was kinked.No patient complications were reported and the patient status was stable.However, returned device analysis revealed shaft break.
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