FDA Adverse Event Malfunction Summary report: N

CATHETER

MDR report key: 24090919 · Received January 16, 2026

Report

Report Number
2124215-2026-03149
Event Type
Malfunction
Date Received
January 16, 2026
Date of Event
December 18, 2025
Report Date
January 15, 2026
Manufacturer
CENTERPOINT SYSTEMS
Product Code
DQY
UDI-DI
00810024670444
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT THIS CATHETER WAS DIFFICULT TO REMOVE FROM THE BODY DUE TO BEING DRILLED BY THE HELIX. THIS CATHETER WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
155407 CATHETER DQY CENTERPOINT SYSTEMS 9287 CL13921 00810024670444

Patients

Seq Age Sex Outcome Treatment
1 78 YR Male