BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7314 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: the returned complaint device consisted of a nc emerge balloon catheter.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube is completely separated 89.9cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks along the device.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 27-jul-2020.It was reported that shaft kink occurred.The target lesion was located in the right coronary artery.A 4.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during the insertion, the shaft kinked.The device was removed and the procedure was completed with another nc emerge balloon.There were no patient complications reported.However, returned device analysis revealed shaft detachment.
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