BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7132 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A 3.00 x 16 synergy drug-eluting stent was selected for use.However, during unpacking, it was noticed that the stent struts appeared to be lifted and deformed.The device was replaced with another stent.A 3.00mm x 12mm emerge balloon catheter was selected for use.However, during preparation upon introduction, the balloon shaft broke.The procedure was completed with another of same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 20cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There were numerous hypotube kinks to the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and the tip of the device was damaged.Product analysis confirmed the reported break as there was separation to the device.There were unreported damages such as hypotube kinks, and tip damage.The damages found to the device are consistent with what can occur during preparation, procedural use, or an interaction with patient anatomy.
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Event Description
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It was reported that shaft break occurred.A 3.00 x 16 synergy drug-eluting stent was selected for use.However, during unpacking, it was noticed that the stent struts appeared to be lifted and deformed.The device was replaced with another stent.A 3.00mm x 12mm emerge balloon catheter was selected for use.However, during preparation upon introduction, the balloon shaft broke.The procedure was completed with another of same device.No patient complications were reported.
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