BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7213 |
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 03/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.During preparation for a percutaneous coronary intervention, a 3.50mm x 15mm nc emerge balloon catheter was selected for used.However, after the opening of the package, the shaft was broken out of the hoop.The procedure was completed with another of same device.There were no patient complications reported.
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Event Description
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It was reported that shaft break occurred.During preparation for a percutaneous coronary intervention, a 3.50mm x 15mm nc emerge balloon catheter was selected for used.However, after the opening of the package, the shaft was broken out of the hoop.The procedure was completed with another of same device.There were no patient complications reported.It was further reported that upon opening the package, the shaft did not break it was just kinked.
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Search Alerts/Recalls
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