CATHETER PASSER
Received Apr 17, 2026 · Event occurred Mar 31, 2026
Report 2182207-2026-01021 · MDR key 24911818
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
- Perforation of Vessels
Narrative
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, A VESSEL WAS INADVERTENTLY NICKED, RESULTING IN BLEEDING. PHYSICIAN ATTEMPTED TO ACHIEVE HEMOSTASIS BY APPLYING PRESSURE WITH GAUZE AND USING CAUTERY, BUT WAS UNSUCCESSFUL. PHYSICIAN MADE AN ADDITIONAL INCISION, IDENTIFIED THE SOURCE OF BLEEDING, AND ACHIEVED HEMOSTASIS THROUGH LIGATION. THIS RESOLVED THE ISSUE.
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.