BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number 83786 |
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 12/21/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device was contaminated.A 4mmx10cm interlock-35 coil was selected for use.During preparation, when the device that arrived was checked, a blood-like stain seemed to have adhered.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was received for product analysis.A sealed box was returned for this complaint, per visual review it was noticed a blood-like stain adhered to the plastic wrap on the outer side.No other issues were identified during the product analysis.
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Event Description
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It was reported that the device was contaminated.A 4mmx10cm interlock-35 coil was selected for use.During preparation, when the device that arrived was checked, a blood-like stain seemed to have adhered.No patient complications were reported.
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Search Alerts/Recalls
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