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: 3005168196-2021-01458.
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The patient was undergoing a coil embolization procedure using penumbra smart coil (smart coil), penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed a smart coil in the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the smart coil and handle were removed.It was also reported that the physician experienced resistance while retracting the smart coil to be removed.Subsequently, upon placing the smart coil on the back table, the smart coil had detached from the pusher assembly.The procedure was completed using other coils.There was no report of an adverse effect to the patient.
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