inforMED
MalfunctionMAJ

CATHETER PASSER

Received May 12, 2026 · Event occurred Apr 20, 2026

Report 25148421 · MDR key 25148421

Device

Generic name

Catheter, Percutaneous, Intraspinal, Short Term

Model number

8591-38

Catalog 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