Catalog Number 5MAXJET7KIT |
Device Problems
Device Damaged Prior to Use (2284); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/28/2019 |
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 thrombectomy procedure, the hospital technologist opened a penumbra system jet7 kit and noticed that the penumbra system jet 7 reperfusion catheter (jet7) was kinked in multiple places prior to removing it from the packaging.The damaged jet7 was found prior to use and therefore, was not used in the procedure.The procedure was completed using another penumbra system jet7 kit.
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Manufacturer Narrative
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Results: the returned jet7 was kinked at approximately 4.0 cm and 7.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed kinks near the proximal end of the device.If the device is retracted at extreme angles out of its packaging tray without removing the top portion of the packaging tray, damage such as this may occur.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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