The returned device sample is entering the investigation process.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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The contract manufacturer conducted an investigation of the returned device, as well as a review of the manufacture process of the device.It was noted that the device evaluation occurred after the decontamination process which would have dislodged any dried blood or other obstructions that may have contributed to this event.All relevant measurements taken revealed the device was within specification.A review of the manufacture process revealed a lumen patency and leak test is performed at 100%.The leak test is the final step of the manufacture process prior to packaging and will detect very tiny holes, tears, and gaps in the device.The device was implanted and in use for more than 20 months prior to this issue a definitive root cause cannot be determined but is most likely not manufacture related.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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