Model Number H7493926220250 |
Device Problems
Bent (1059); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that stent damage occurred.During preparation of a 2.50 x 20mm synergy¿ drug-eluting stent, it was noted that the distal side of the stent struts were lifted during flushing.The procedure was completed with a 2.5x18mm non-bsc stent.No patient complications nor injuries were reported.
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Search Alerts/Recalls
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