BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7212 |
Device Problem
Break (1069)
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Patient Problems
Chest Pain (1776); No Consequences Or Impact To Patient (2199)
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Event Date 05/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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Returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded, with blood in the inflation lumen (shaft) and balloon.The tip, markerbands, balloon, proximal weld, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed fracture in the hypotube located 66cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces in the separated hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no damage or defect with the device.
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the proximal left anterior descending (lad) artery.Two non-bsc guide wires in used in a procedure together with a 3.50mm x 12mm nc emerge balloon catheter for post-dilation.After inflating for 21 seconds, a leak was noted emanating from the guide.The device was withdrawn; however, the shaft broke which left the balloon in the proximal lad.Snaring the detached part was attempted but failed.Finally, another balloon was advanced and inflated at 5 atmospheres, trapping the separated shaft and successfully removing from the patient.No further complications were reported and the patient was not harmed.
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Manufacturer Narrative
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H6 patient codes corrected from 2199 no consequences or impact to patient to 1776 chest pain.Returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded, with blood in the inflation lumen (shaft) and balloon.The tip, markerbands, balloon, proximal weld, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed fracture in the hypotube located 66cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces in the separated hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no damage or defect with the device.
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the proximal left anterior descending (lad) artery.Two non-bsc guide wires in used in a procedure together with a 3.50mm x 12mm nc emerge balloon catheter for post-dilation.After inflating for 21 seconds, a leak was noted emanating from the guide.The device was withdrawn; however, the shaft broke which left the balloon in the proximal lad.Snaring the detached part was attempted but failed.Finally, another balloon was advanced and inflated at 5 atmospheres, trapping the separated shaft and successfully removing from the patient.No further complications were reported and the patient was not harmed.It was further reported that after the shaft broke, the patient experienced chest pain but did not have any st-t wave abnormalities or hemodynamic issues.
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