VISUALASE

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. WHILE WALKING THROUGH A DEMONSTRATION, IT WAS NOTICED THAT THERE WAS A SALINE LEAK/DRIP AT THE BLUE STRAIN RELIEF SHEATH WHILE IN THE MAGNETIC RESONANCE IMAGING (MRI) MACHINE. TOWELS WERE USED TO CONTAIN THE DRIPPAGE AND CLEAN IT UP WITH NO APPARENT DAMAGE CAUSED. AFTER THE DRY RUN, IT WAS NOTICED THAT THE LOCAL REPRESENTATIVE (REP) COULD JUST PULL THE OUTER CANULA OF THE INNER CANULA/LUMEN AS IF THE ADHESION SPOT INSIDE THE BLUE STRAIN RELIEF WAS NOT HOLDING. THE REP HAD ALSO NOTICED WHEN THEY SET UP THAT THE STIFFENING STYLET WAS SLIGHTLY DIFFICULT TO INSERT, BUT IT DID PASS WITH SOME FRICTION. IT WAS NOTED THAT THE ACCESSORY KIT WAS "WAY" PAST EXPIRATION DATE. IT HAD EXPIRED ON 2020-OCT-25. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

A05: ADHESION NOT HOLDING, STYLET DIFFICULT TO INSERT A0504: SALINE LEAK D10: PRODUCT ID: UNK_VISUALASE_SYS (SERIAL: (B)(6); PRODUCT ID: 9735571 (2018101251); PRODUCT TYPE: 2543-MNAV - SYSTEM; H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.