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Catalog Number DH1 |
Device Problems
Device Damaged Prior to Use (2284); Difficult or Delayed Activation (2577)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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During preparation for a medical procedure, the physician was testing the penumbra coil 400 detachment handle (handle) and reported that the trigger was slow and did not make the ''popping'' sound.The issue with the handle was found prior to use and, therefore, the handle was not used in the procedure.Subsequently, the physician lost access to the target vessel and the procedure was ended.
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Manufacturer Narrative
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Results: the penumbra coil 400 detachment handle (handle) was undamaged.Conclusions: evaluation of the returned handle revealed a fully functional device.During the functional testing, the handle was tested on a handle test fixture and tested within specification.The handle was found to make a dull click instead of an expected ¿popping sound.¿ however, this did not affect the device functionality.Penumbra handles are visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Search Alerts/Recalls
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