Catalog Number 5MAXACE068KIT |
Device Problems
Fracture (1260); Material Separation (1562); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 57.0 cm from the hub.Conclusions: evaluation confirmed that the ace 68 was fractured.This type of damage typically occurs if the ace 68 is withdrawn from the packaging shell prior to removing the tubing tray.Penumbra catheters are inspected during in-process inspection and during quality inspection after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 hospital staff noticed that the shaft of the penumbra system ace 68 reperfusion catheter (ace 68) was fractured upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace 68 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new ace 68.
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Search Alerts/Recalls
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