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 04/23/2019 |
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 physician noticed that the penumbra system jet 7 reperfusion catheter (jet7) from a penumbra system jet7 kit appeared to be kinked upon removal from the 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 penumbra system jet 7 reperfusion catheter (jet7) was kinked at approximately 64.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a kink.If the packaging tray lid is not removed prior to removal of the jet7 from its packaging tray, the device may become kinked.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.H3 other text : placeholder.
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Search Alerts/Recalls
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