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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While preparing a third penumbra smart coil (smart coil) on the back table for a coil embolization procedure, the technologist noticed that the coil came out of its introducer sheath upon removal from its dispenser hoop.The technologist then made several attempts to retract the coil back into its introducer sheath but was unable to resheath the coil.Therefore, the smart coil was not used for the procedure and did not come into contact with the patient.The procedure was completed using new smart coils.
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