VENTRICLEAR¿

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF THIS EVENT, THE EVENT WAS DETERMINED TO BE A DUPLICATE. ANY FURTHER INFORMATION REGARDING THIS EVENT WILL BE SUBMITTED UNDER REGULATORY REPORT 2021898-2024-00092. 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.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL VENTRICULAR DRAINAGE (EVD) CATHETER. IT WAS REPORTED THAT WHILE ATTEMPTING TO R EADJUST THE PATIENT'S EVD CATHETER DRESSING, WHICH WAS COMPLETELY OFF OF THE PORTION COVERING THE TUBING INSERTION, THE PATIENT EXPERIENCED A SHARP PAIN WHILE THE REGISTERED NURSE'S (RN) HAND WAS ON THE DRESSING PULLING FORCIBLY AWAY FROM RN'S HAND WHILE AT THE SAME TIME REACHING THEIR HAND UP TO WHERE THE RN'S HANDS WERE PUSHING THEIR HANDS AWAY. AS A RESULT, THE CATHETER BROKE LEAVING IT IN TWO PIECES, ONE ATTACHED TO THE PATIENT AND ONE FLOATING IN THE AIR. THE RN IMMEDIATELY CLAMPED TUBING AND CALLED THE DOCTOR FOR ASSESSMENT. THE TUBING WAS REATTACHED WITHOUT ISSUE BY THE CERTIFIED PHYSICIAN ASSISTANCE (PA-C) AND WAVE FORM REASSESSED.

Additional Manufacturer Narrative

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.