Catalog Number 4002C0312 |
Device Problems
Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.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 in the left internal iliac artery (iia) to treat type ii endoleak using penumbra coils 400 (pc400s).It was reported that the patient anatomy was mildly tortuous.During the procedure, the physician placed two non-penumbra coils and one pc400 in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400 through the microcatheter, the physician experienced resistance right after inserting the pc400 into the microcatheter and the pc400 became stuck; therefore it was removed.The procedure was completed using another coil and the same microcatheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: the embolization coil was intact with the pusher assembly and had offset coil winds throughout its length conclusions: evaluation of the returned device revealed the embolization coil had offset coil winds.This type of damage typically occurs due to forceful manipulation of the pc400 against resistance.The offset coil winds caused resistance when resheathing and advancing the pc400 through its introducer sheath.The root cause of the initial resistance experienced during the procedure could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils 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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