Model Number H7493927615250 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured due to the severe stenosis.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
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Manufacturer Narrative
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Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The balloon was loosely folded.Inspection of the device revealed a longitudinal burst that was 9mm in length.Inspection of the remainder of the device revealed no other damage or irregularities.There is no indication the device was inflated over the rated burst pressure.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.Bsc id: (b)(4).Tw: 4902193.
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.50mm x 15mm nc emerge® balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured due to the severe stenosis.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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