MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. CATHETER PASSER; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number	8591-38
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Great Vessel Perforation (2152); Foreign Body In Patient (2687)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: CATHETER PASSER
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 25148421
• Report Number: 25148421
• Device Sequence Number: 15801924
• Product Code: MAJ
• UDI-Device Identifier: 00763000031404
• UDI-Public: (01)00763000031404(17)301026(10)0232769169
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026
• Report Date (Section F): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: 0232769169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/27/2026