Model Number 401736 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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Combination product: yes.
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Event Description
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Bioflow vii: after successful orsiro stent implantation patient experienced some persistent oozing from the right radial site.Patient stayed overnight for observations on right radial access site.
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Manufacturer Narrative
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Combination product: yes.Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.
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Search Alerts/Recalls
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