FDA Adverse Event
Malfunction
Summary report: N
THROMBOLEX
MDR report key: 24699300
·
Received March 26, 2026
Report
- Report Number
- 3015489145-2026-00005
- Event Type
- Malfunction
- Date Received
- March 26, 2026
- Date of Event
- February 26, 2026
- Report Date
- March 24, 2026
- Manufacturer
- THROMBOLEX, INC.
- Product Code
- QEY
- PMA / PMN Number
- K231653
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION INTO CORRECTIVE/PREVENTIVE ACTIONS IN PROCESS.
Description of Event or Problem · 0
PHYSICIAN UTILIZED A FEMORAL APPROACH WITH THE DEVICE. DEVICE WAS INTRODUCED INTO THE PATIENT WITHOUT ISSUE BUT WHEN INFUSION BEGAN, LIQUID EXITED AT THE HANDLE/SHAFT CONNECTION POINT. NO PATIENT HARM. DEVICE WAS REPLACED WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447847 | THROMBOLEX | BASHIR .035 ENDOVASCULAR CATHETER | QEY | THROMBOLEX, INC. | 8201 | 343453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |