Model Number H7493925232270 |
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 03/14/2018 |
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 unpacking of a 32 x 2.75mm promus premier¿ drug-eluting stent, it was noted that the stent struts were bent.The device never entered the patient's body.No patient complications were reported.
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Search Alerts/Recalls
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