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 evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded and there was blood in the inner lumen/shaft.Analysis of the tip, balloon, inner/outer shaft, port weld/exit notch and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube and a hypotube fracture located 76.7cm from the tip.The fracture faces were ovalized, suggesting the area had been kinked prior to being separated.Inspection of the rest of the device found no other damage or defects.
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Event Description
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Reportable based on device analysis completed on 30jan2021.It was reported that shaft kink occurred.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left coronary artery.A 3.0mm x 12mm quantum maverick was selected for use.However, during procedure, the shaft was kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a shaft separation.
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