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Catalog Number 400SMTSFT0515 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/15/2017 |
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.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the introducer sheath of a smart coil was accidentally removed as the hospital technician was removing the smart coil from the packaging hoop.As the technician was attempting to re-sheathe the smart coil, it was dropped on the floor.The smart coil was dropped prior to use, and therefore it was not used in the procedure.The procedure was completed using a new smart coil.
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Search Alerts/Recalls
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