Model Number 9530 |
Device Problem
Contamination (1120)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that the device was contaminated.An 8x2.25mm synergy drug-eluting stent was selected for treatment.However, the device was contaminated during use.
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Event Description
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It was reported that the device was contaminated.An 8x2.25mm synergy drug-eluting stent was selected for treatment.However, the device was contaminated during use.It was further reported that this event was reported in error.The complaint reporter misread the reported information.The reported event of accidental de-sterilization does not meet complaint criteria and is considered accidental damage.Therefore, this incident no longer meets reporting criteria.
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Manufacturer Narrative
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Device is a combination product.
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Search Alerts/Recalls
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