Catalog Number 5MAXACE068KIT |
Device Problems
Break (1069); Material Separation (1562); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Please note that the following device code is also associated with this complaint: (b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 59.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that it was fractured.This type of damage typically occurs if the ace 68 is withdrawn from the packaging shell prior to removing the tubing tray.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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During preparation for a thrombectomy procedure, the penumbra system ace 68 reperfusion catheter (ace 68) split in half while being removed from the sterile packaging tray.The damage to the ace 68 occurred prior to use and therefore, was not used for the procedure.The procedure was completed using a new ace 68.
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Search Alerts/Recalls
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