Model Number 39540 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/04/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was contaminated.The target lesion was located in the superficial femoral artery.A 150cm rubicon 18 was selected for use.During unpacking, it was noted that the bottom of the package was not sealed and the device became contaminated.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.The rubicon device was visually and microscopically analyzed for any damage.The original sterile packaging was not returned.The device was in the shipping tube when received.The device was removed from the tube and no damage was noticed on the shaft.Inspection of the remainder of the device revealed no damage or irregularities.
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Event Description
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It was reported that the device was contaminated.The target lesion was located in the superficial femoral artery.A 150cm rubicon 18 was selected for use.During unpacking, it was noted that the bottom of the package was not sealed and the device became contaminated.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
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Search Alerts/Recalls
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