CATHETER PASSER

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO USE THE CATHETER PASSER DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, AND THE SHAFT OF THE PASSER SEEMED TO BE MORE MALLEABLE THAN INTENDED. THE DOCTOR WAS UNABLE TO SUCCESSFULLY PASS THE CATHETER THROUGH THE CATHETER PASSER. IT WAS NOTED THE CATHETER PASSER WAS TOO DAMAGED TO BE RETURNED. THE DOCTOR USED A SOLID REUSABLE PASSER TO COMPLETE THE PROCEDURE. THIS RESULTED IN A PROCEDURE DELAY OF 5 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

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.