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 |