CATHETER PASSER
Received May 12, 2026 · Event occurred Apr 20, 2026
Report 25148421 · MDR key 25148421
Device
Generic name
Catheter, Percutaneous, Intraspinal, Short Term
Manufacturer
Medtronic Ps Medical, Inc.Model number
8591-38Catalog number
8591-38
Lot number
0232769169
Patient
81 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Low Blood Pressure/ Hypotension
- Failure of Implant
- Great Vessel Perforation
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING THE PROCEDURE FOR A HYPOGLOSSAL NERVE STIMULATOR IMPLANT, THE DOCTOR STARTED TO TUNNEL WITH THE CATHETER PASSER TO ATTACH THE LEAD TO THE UNIT. WHEN DOING SO THE TIP OF THE PASSER BROKE OFF INSIDE THE PATIENT. THE DOCTOR WAS ABLE TO FIND THE TIP; HOWEVER THE PATIENT STARTED TO HAVE INCREASE IN BLEEDING, AND HIS BLOOD PRESSURE STARTED TO DROP. PATIENT GOT STABILIZED, BUT WE HAD TO CALL VASCULAR AND CARDIAC SURGERY TO COME ASSESS AND THE PATIENT BECAUSE BLEEDING WAS DIFFICULT TO CONTROL. ANESTHESIA ORDERED AND GAVE TWO UNITS OF BLOOD. ONCE THOSE PHYSICIANS ARRIVED AND ASSESSED THE SITUATION, THE VASCULAR SURGEON WAS ABLE TO REPAIR THE INTERNAL JUGULAR VEIN AND THE PATIENT WAS STABILIZED. SURGICAL PROCEDURE WAS FINISHED AND PATIENT WAS TAKEN OVER TO THE MAIN OR PACU [POST ANESTHESIA RECOVERY UNIT], WHILE PATIENT REMAINED STABLE. PRODUCT INFO: REF# 8591-38 CATHETER PASSER DISPOSABLE VENDOR MEDTRONIC LOT # 0232769169 EXP: 10/26/2030