Model Number 10607 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/16/2018 |
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 packaging issue was encountered.During preparation of a synergy stent, the labeling on the box indicated the device contained to be a 3.00x32mm synergy; however, the device inside was a 3.00x38mm synergy.The procedure was completed with a different device.There was no serious injury or adverse patient effect.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: a sealed synergy ii us mr 3.00 x 38 mm inner tyvek pouch was returned for analysis.No damage was noted and all labelling legible.A label had been removed from the front of the pouch.The stent delivery system (sds) and hoop were present in the pouch.The device details were consistent with the documented details on the label on the tyvek pouch.A visual examination of the stent found no issues.The crimped stent length was measured and the result was within crimped stent length specification for synergy 3.00x38mm.
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Event Description
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It was reported that packaging issue was encountered.During preparation of a synergy stent, the labeling on the box indicated the device contained to be a 3.00x32mm synergy; however, the device inside was a 3.00x38mm synergy.The procedure was completed with a different device.There was no serious injury or adverse patient effect.
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Search Alerts/Recalls
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