Catalog Number 5MAXACE068KIT |
Device Problems
Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.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 thrombectomy procedure, the hospital staff noticed that the tip of the penumbra system ace 68 reperfusion catheter (ace68) was ovalized upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace68 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new kit.
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Manufacturer Narrative
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Results: the penumbra system ace 68 reperfusion catheter (ace68) was ovalized on the distal tip.Conclusions: evaluation of the returned device revealed the distal tip was ovalized.This damage may have occurred due to pinching or other forceful handling of the ace68 during removal from the packaging.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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Search Alerts/Recalls
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