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Model Number 4002C1557 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2021 |
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 coil embolization procedure using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 through a px slim.However, it was noticed under fluoroscopy that the pc400 did not exist through the distal tip of the px slim.Therefore, the physician removed the pc400 and re-sheathed it.Afterwards, on the back table, the physician attempted to advance the pc400 but only the pusher assembly of the pc400 was found.The procedure was completed using another pc400.There was no report of adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned pc400 revealed that the pull wire was advanced distal to the pusher assembly ddt.If the device is forcefully advanced against resistance, damage such as this may occur.This damage likely contributed to the embolization coil to detach from the pusher assembly during the procedure.The detached embolization coil was not returned for evaluation.Penumbra coils 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.H3 other text: placeholder.
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Search Alerts/Recalls
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