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Catalog Number 400SMTXSFT0306 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 11/13/2017 |
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.This report is associated with mfr report number: 3005168196-2018-00015.The device was implanted in the patient.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handled).During the procedure, while attempting to detach a smart coil using the handle, the physician noticed that smart coil occasionally snagged inside the handle.It was reported that on one of the occasion, the smart coil pusher assembly snagged inside the handle and the smart coil was pulled back into the microcatheter and possibly sheared.
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Search Alerts/Recalls
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