BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493926730250 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(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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Same case as mdr id: 2134265-2016-12452 and 2134265-2016-12459.It was reported that three emerge mr balloons, a 2.25mm x20mm, a 2.5mmx30mm and a 27.5mm x30mm all ruptured.The procedure was completed with a cutting balloon.No patient complications were reported.
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Search Alerts/Recalls
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