CATHETER PASSER

Additional Manufacturer Narrative

INFORMATION WAS INITIALLY REPORTED IN REGULATORY REPORT # 2182207-2026-01150. ANY FURTHER UPDATES REGARDING THIS EVENT WILL BE REPORTED AS SUPPLEMENTAL REPORTS TO REGULATORY REPORT # 9612501-2026-01268. 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.

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

ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA COMPANY REPRESENTATIVE STATING THAT TO RESOLVE THE EVENT THE PHYSICIAN HAD TO DO AN INTERNAL JUGULAR REPAIR. AFTER THAT THE PATIENT WENT TO REGULAR POST-ANESTHESIA CARE UNIT (PACU) AFTER SURGERY THEN WENT HOME WITH NO COMPLICATIONS.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE CATHETER PASSER TIP BROKE OFF INSIDE THE PATIENT DURING AN ENT PROCEDURE. IT WAS UNKNOWN IF THERE WERE ANY FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THIS ISSUES. THE REP RECEIVED AN EMAIL FROM THE SURGERY CENTER WHICH PROVIDED THE FOLLOWING INFORMATION: THERE WAS AN UNANTICIPATED EVENT WITH A HYPOGLOSSAL NERVE IMPLANT SURGERY. THE HCP USED A TUNNELER PER USUAL, AND THE TIP OF THE TUNNELER BROKE OFF. THEY HAD TO SEARCH FOR THE BROKEN PIECE, AND THE PATIENT HAD A LOT OF BLOOD LOSS. VASCULAR AND THORACIC SURGEONS HAD TO COME HELP. IT AFFECTED EITHER THE SUBCLAVIAN OR JUGULAR VESSEL. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. IT WAS UNKNOWN IF THE PRODUCT WAS REPLACED.

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.