Model Number 7134 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
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 the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and severely calcified.The balloon was inflated twice at 10-12 atmospheres for 3 seconds each.The balloon ruptured at 12 atmospheres.
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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 were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.At 47mm from the tip of the device, the guidewire lumen was buckled with a length of 4mm.The buckle contained a prolapse of the lumen and a puncture hole consistent with an interaction of a guidewire.Product analysis could not confirm reported burst.Analysis shows the guidewire lumen was buckled and punctured which is consistent with an interaction with a guidewire during procedural use.The balloon folds were also tight which indicates the balloon was not inflated.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and severely calcified.The balloon was inflated twice at 10-12 atmospheres for 3 seconds each.The balloon ruptured at 12 atmospheres.
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Search Alerts/Recalls
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