Model Number H7493926216400 |
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 10/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr.: the device was not received 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 4.00 x 16mm synergy¿ stent, it was noted that the tip of the stent strut was lifted.The procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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