BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7133 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in two pieces.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a shaft separation (fracture) in the hypotube located 67.3 cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces were ovalized, suggesting the fractured area was kinked prior to becoming separated.Inspection of the rest of the device found no other damage or defect.
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Event Description
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Reportable based on device analysis completed on 20jan2021.It was reported that shaft kink occurred.The 70% stenosed target lesion was located in mildly tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during procedure the device was kinked.The device was completely removed from the patient's body and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed shaft detached/separated.
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