BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7214 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address 1: (b)(6).
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Event Description
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It was reported that shaft break occurred.The patient presented with ischemia and underwent percutaneous coronary intervention.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.While inserting the balloon into the guide catheter, a small kink was created when the shaft collapsed.The balloon catheter was continued to be used and was further inserted into the guide catheter.While the balloon catheter was being pressed forward, the shaft completely broke off.The device was pulled out within the guide catheter.Another guide catheter and a non-boston scientific balloon were used to complete the procedure.No patient complications were reported.
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: returned product consisted of the nc emerge balloon catheter with a non-bsc guide catheter.The hypotube, shaft, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the device revealed that there were numerous kinks throughout the hypotube.The hypotube was separated 76cm distal of the strain relief.The ends of the separation were ovaled, indicating that the hypotube was kinked prior to separation.The guide catheter used in the procedure was returned for analysis, so it was used for functional testing.The tip of the catheter was advanced into the returned guide catheter and advanced up to the separation with no resistance or issues.Product analysis confirmed the reported event, as hypotube was kinked and separated.
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Event Description
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It was reported that shaft break occurred.The patient presented with ischemia and underwent percutaneous coronary intervention.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.While inserting the balloon into the guide catheter, a small kink was created when the shaft collapsed.The balloon catheter was continued to be used and was further inserted into the guide catheter.While the balloon catheter was being pressed forward, the shaft completely broke off.The device was pulled out within the guide catheter.Another guide catheter and a non-boston scientific balloon were used to complete the procedure.No patient complications were reported.
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