BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493927615400 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at the time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.A 4.00mmx15mm nc emerge® balloon catheter was advanced for dilation.There was no visual issue prior to use.However, during the first inflation at 10 atmospheres, the balloon ruptured after being inflated for 10 seconds.The device was completely removed from the patient's body.The procedure was successfully completed with a non-bsc device.No patient complications were reported and the patient's status was good.
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