Model Number PNML6F088904M |
Device Problems
Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2021 |
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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The patient was undergoing a medical procedure in the middle cerebral artery (mca) to treat an arteriovenous malformation (avm) using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance while inserting a dilator into a neuron max and decided to remove the neuron max.Upon removal, it was noticed that the neuron max was stretched at the distal end and kinked at the proximal end.The procedure was completed using a non-penumbra sheath.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned neuron max confirmed that the catheter was stretched.If the neuron max is forcefully retracted against resistance, damage such as stretching may occur.Further evaluation revealed a kink in the proximal shaft.This damage was incidental to the reported complaint and the root cause could not be determined.During the functional test, the dilator was able to be advanced through the neuron max with resistance due to the kink and stretching on the catheter shaft.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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Search Alerts/Recalls
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