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Model Number 400SMTSTD0820 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2021 |
Event Type
malfunction
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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.Device code 1: 3191 is used because no appropriate term or code was available to describe that the smart coil could not be deployed.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil).During the procedure, it was reported that the smart coil did not deploy.Therefore, the smart coil was removed.The procedure was completed using another coil.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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