BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493926706300 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at 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 excessive balloon length occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal circumflex artery.After a synergy stent was implanted in the lesion, a 3.00mm x 6mm nc emerge® balloon catheter was advanced to post dilate the lesion.However, it was noted that the distal end of the balloon extended outside of the marker band.The procedure was completed with this device.No patient complications were reported and the patient's status was excellent.
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