Catalog Number 5MAXJET7KIT |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/11/2019 |
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 staff noticed that the penumbra system jet 7 reperfusion catheter (jet7) was broken in half upon removal from its packaging.The damage to the jet7 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new jet7.
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Manufacturer Narrative
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Results: the returned jet7 was fractured at approximately 6.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a fractured device.If the packaging lid is not removed from the tray prior to removal of the device, the device may become stuck inside the tray.If the device is forcefully retracted, it will likely become fractured.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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