Catalog Number PNML6F088904M |
Device Problems
Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the distal tip of the neuron max was fractured.The neuron max was kinked in multiple locations along its length.Conclusions: evaluation of the returned neuron max revealed the distal tip of the catheter was fractured.This type of damage can occur when the mandrel is unsecured from the packaging card and the catheter is subsequently retracted.The catheter can then become pinned between the packaging tubing and mandrel.If the device is then forcefully retracted against this resistance, the neuron max distal tip may become fractured.Further evaluation revealed kinks along the length of the neuron max.These kinks were likely incidental and occurred during packaging the device for return to penumbra.Penumbra catheters are visually 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 medical procedure, the tip of the neuron max 6f 088 long sheath (neuron max) broke off and remained in the package when the hospital technologist was removing the neuron max from the packaging.The damage to the neuron max was found prior to use.Therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max.
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Manufacturer Narrative
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Box 2.Returned to manufacturer on (mm/dd/yyyy): the date was inadvertently selected as 5/22/2018, it should be 5/15/2018.
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Search Alerts/Recalls
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