CATHETER PASSER

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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING THE USE OF A CATHETER PASSER MOST REASONABLY USED TO IMPLANT AN INSPIRE PRODUCT. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE TUNNELING WITH A MEDTRONIC CATHETER PASSER, THE TIP SNAPPED OFF. PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP BY CREATING A THIRD INCISION BELOW THE CLAVICLE, AT WHICH POINT BLEEDING WAS OBSERVED. UPON REMOVAL OF THE TIP, THE PHYSICIAN DETERMINED THAT THE STIMULATION LEAD HAD PIERCED THE EXTERNAL JUGULAR VEIN. MANUAL PRESSURE WAS APPLIED WITHOUT RESOLUTION. A VASCULAR SURGEON AND A CARDIOTHORACIC SURGEON WERE BROUGHT IN TO ASSIST. THE VASCULAR SURGEON WAS ABLE TO CONTROL THE BLEEDING AND ACHIEVE HEMOSTASIS. THE PHYSICIAN THEN RE-TUNNELED THE STIMULATION LEAD BENEATH THE VEIN AND COMPLETED THE IMPLANT PROCEDURE WITHOUT FURTHER ISSUES. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND WAS EXPECTED TO BE DISCHARGED. IMAGING WAS ALSO PERFORMED AND CONFIRMED NO PNEUMOTHORAX.