CATHETER PASSER

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT ON (B)(6), 2026, THE PATIENT ENTERED THE OPERATING ROOM AND UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE UNDER GENERAL ANESTHESIA DUE TO HYDROCEPHALUS. THE DEVICE USED INTRAOPERATIVELY WAS A CEREBROSPINAL FLUID FLOW CONTROL SHUNT AND ACCESSORIES SET. A SINGLE-USE TUNNELING TOOL WAS USED TO CREATE A SUBCUTANEOUS TUNNEL. AFTER THE TUNNELING TOOL WAS WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE INNER STYLET HAD FRACTURED, WITH A MISSING PORTION MEASURING APPROXIMATELY 3.3 MM × 3.3 MM. AFTER THE EVENT OCCURRED, THE OPERATOR IMMEDIATELY STOPPED THE PROCEDURE. THE SURGICAL TEAM CONDUCTED A CAREFUL SEARCH WITHIN THE OPERATIVE FIELD, USED C-ARM FLUOROSCOPY, AND REQUESTED AN ULTRASOUND CONSULTATION. THE LEAD SURGEON CONFIRMED THAT THE MISSING FRAGMENT WAS NOT PRESENT IN THE PATIENT¿S BODY. THE HEAD NURSE AND THE BIOMEDICAL ENGINEERING DEPARTMENT WERE NOTIFIED IMMEDIATELY. THE CONSUMABLE WAS COMPREHENSIVELY INSPECTED. THE LEAD SURGEON REPORTED THAT THE DEVICE WAS USED NORMALLY DURING THE PROCEDURE, WITH NO EXCESSIVE FORCE OR IMPROPER HANDLING. NO HARM WAS CAUSED TO THE PATIENT. IT WAS NOTED THAT THIS PROLONGED THE PROCEDURE TIME.

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.