Lot Number 22515291 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/02/2019 |
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 a foreign material was present inside the device.During preparation of a 32mmx2.50mm promus elite stent, the physician noticed a long, thin, white, silvery hair-like fiber on the device.The procedure was completed with another of the same device.No patient complications were reported the device did not enter the patient's body.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: the promus elite us mr 2.50 x 32 mm device was not returned for analysis.Foreign material returned attached to promus elite label.Fm (foreign material) appeared to be a clear plastic fibrous material.Dried brown substance was also observed on the plastic that was packaging the fm.No other issues were noted during analysis.
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Event Description
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It was reported that a foreign material was present inside the device.During preparation of a 32mmx2.50mm promus elite stent, the physician noticed a long, thin, white, silvery hair-like fiber on the device.The procedure was completed with another of the same device.No patient complications were reported the device did not enter the patient's body.
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Search Alerts/Recalls
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