FDA Adverse Event
Malfunction
Summary report: N
NOVACROSS MICROCATHETER
MDR report key: 9711168
·
Received February 14, 2020
Report
- Report Number
- 3011816495-2020-00001
- Event Type
- Malfunction
- Date Received
- February 14, 2020
- Date of Event
- January 16, 2020
- Report Date
- February 13, 2020
- Manufacturer
- NITILOOP LTD
- Product Code
- DQY
- UDI-DI
- 07290017436012
- PMA / PMN Number
- K172297
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN USED THE DEVICE IN AN EXTREME CONDITION, IN A HIGHLY CALCIFIED LESION BELOW THE KNEE.
Description of Event or Problem · 1
TIP OF DEVICE BROKE OFF IN CALCANEAL ARTERY. LEFT IN PLACE. THE USER PLACED A STENT TO ATTACH THE TIP TO THE ARTERY ENDOTHELIUM. PROCEDURE COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178171 | NOVACROSS MICROCATHETER | PERCUTANEOUS CATHETER | DQY | NITILOOP LTD | NOVACROSS XTREME | FP.000042 | 07290017436012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |