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Catalog Number 400SMTXSFT0203 |
Device Problem
Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2022 |
Event Type
malfunction
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Event Description
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The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician successfully detached smart coils in the target vessel using the handle.The physician then advanced another smart coil to the target vessel and attempted to detach it using the handle; however, the coil failed to detach after multiple attempts.Subsequently, while retracting the smart coil, the smart coil unintentionally detached.Therefore, the physician advanced the detached smart coil into the target location using the pusher assembly of the coil.The procedure was completed using non-penumbra coils.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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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