CATHETER PASSER
Received Mar 26, 2026 · Event occurred Mar 18, 2026
Report 2182207-2026-00805 · MDR key 24698419
Device
Generic name
Catheter, Percutaneous, Intraspinal, Short Ter
Manufacturer
Medtronic NeuromodulationModel number
8591-38Catalog number
8591-38
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
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 PATIENT EXPERIENCED BLEEDING. PHYSICIAN MADE AN ADDITIONAL INCISION AT THE ANTERIOR BASE OF THE NECK NEAR THE CLAVICLE, IDENTIFIED THE SOURCE OF BLEEDING, AND ACHIEVED HEMOSTASIS USING A COMBINATION OF TRANEXAMIC ACID (TXA), CAUTERY, PRESSURE, AND A HEMOSTATIC POWDER. THIS RESOLVED THE ISSUE.