Model Number 10666 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone number - (b)(6).
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Event Description
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It was reported that device sterility was compromised.During unpacking of a 28 x 2.50mm promus premier select drug eluting stent, the physician found a hair in the packaging.The hair was attached at the inside of the packaging, at the inner foil of the transparent packaging.The device had not been completely removed from the packaging when the hair was found.There were no patient complications reported.
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Manufacturer Narrative
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E1: initial reporter phone number - (b)(6).Device evaluated by manufacturer: a sealed tyvek pouch containing a carrier tube (i.E., coiled hoop) with the promus premier select device inside was returned for product analysis.A black fiber was observed sealed inside tyvek pouch and visible at the top right corner above the label.The foreign material was not in direct contact with the carrier tubing which protects the promus premier select device.Laboratory testing of the observed fiber determined that the foreign material was consistent with a hair.
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Event Description
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It was reported that device sterility was compromised.During unpacking of a 28 x 2.50mm promus premier select drug eluting stent, the physician found a hair in the packaging.The hair was attached at the inside of the packaging, at the inner foil of the transparent packaging.The device had not been completely removed from the packaging when the hair was found.There were no patient complications reported.
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Search Alerts/Recalls
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