Model Number 7312 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2019 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in a calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.The device was replaced with a 2.50x15mm nc emerge.No patient complications were reported and the patient was stable.
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Manufacturer Narrative
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Describe event or problem updated.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in a calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.The device was replaced with a 2.50x15mm nc emerge.No patient complications were reported and the patient was stable.It was further reported that the target lesion was 70% stenosed and was located in a moderately calcified vessel.The ruptured balloon was completely removed from the patient's body.
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Search Alerts/Recalls
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