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 12/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications reported.
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Event Description
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It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There were numerous hypotube kinks to the device.There was contrast in the inflation lumen and blood in the guidewire lumen.There was blood within the tight folds of the tightly folded balloon.Product analysis could not confirm reported break as there was no break in the nc emerge balloon catheter.However, analysis can confirm the reported kink as the hypotube of the device was kinked.
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