Catalog Number 400SMTSTD1545 |
Device Problem
Kinked (1339)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/15/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while advancing a smart coil in a non-penumbra microcatheter, the smart coil pusher assembly became kinked at the point of the junction with the introducer sheath; therefore, it was removed.The procedure was completed using additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
|
|
Manufacturer Narrative
|
Expiration date: 9/20/2017.
|
|
Search Alerts/Recalls
|