ARTEMIS NEURO EVACUATION DEVICE

Description of Event or Problem

THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THE CASE WAS NEARLY COMPLETE WHEN THE ARTEMIS BECAME CLOGGED AFTER APPROXIMATELY NINETY MINUTES OF USE. AT THAT POINT, THE PHYSICIAN REALIZED THEY WERE ON THE WRONG TRAJECTORY AND NOTICED A VESSEL INJURY TO THE RIGHT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). THE CLOGGED ARTEMIS WAS REMOVED AND REPLACED WITH A NEW DEVICE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TO ADDRESS THE VESSEL INJURY, THE PHYSICIAN PERFORMED IRRIGATION AND ELECTRO-CAUTERY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT STATUS.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

Additional Manufacturer Narrative

PLEASE NOTE THAT THE FOLLOWING SECTIONS ARE UPDATED ON THIS FOLLOW UP #1 MFR REPORT: 1. SECTION H. BOX 6. HEALTH EFFECT CLINICAL CODE 1. 2. SECTION H. BOX 6. HEALTH EFFECT IMPACT CODE 1 & HEALTH EFFECT IMPACT CODE 2. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. EVALUATION OF THE RETURNED ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) COULD NOT CONFIRM THE REPORTED CLOG. EVALUATION REVEALED AN UNDAMAGED, FUNCTIONAL DEVICE. DURING EVALUATION, FLUID WAS ASPIRATED THROUGH THE ARTEMIS, AND THE BIDENT ROTATED WITHOUT AN ISSUE WHEN THE POWER BUTTON WAS PRESSED. PENUMBRA DEVICES ARE INSPECTED AT INCOMING QUALITY CONTROL WHICH INCLUDES A VISUAL INSPECTION AS WELL AS A VERIFICATION OF TEST RESULTS TO ENSURE SPECIFICATIONS FOR EACH OUTPUT ARE MET. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.