FDA Adverse Event
Malfunction
Summary report: N
ZILIENT
MDR report key: 17868859
·
Received October 4, 2023
Report
- Report Number
- 3006010712-2023-00049
- Event Type
- Malfunction
- Date Received
- October 4, 2023
- Date of Event
- September 25, 2023
- Report Date
- November 10, 2023
- Manufacturer
- CARDIOVASCULAR SYSTEMS, INC
- Product Code
- DQX
- UDI-DI
- 10852528005602
- PMA / PMN Number
- K120137
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.
Additional Manufacturer Narrative · 0
CORRECTION TO A PREVIOUSLY SUBMITTED MDR: 3006010712-2023-00049. BRAND NAME: CSI,30G 300-018 TO ZILIENT. MANUFACTURER NAME: LAKE REGION MEDICAL TO CARDIOVASCULAR SYSTEMS, INC.
Additional Manufacturer Narrative · 0
COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.
Description of Event or Problem · 0
A ZILIENT GUIDE WIRE WAS UNABLE TO CROSS A CALCIFIED LESION. THE WIRE WAS COMPLETELY UNBRAIDED. THE PATIENT WAS STABLE.
Description of Event or Problem · 0
A ZILIENT GUIDE WIRE WAS UNABLE TO CROSS A CALCIFIED LESION. THE WIRE WAS COMPLETELY UNBRAIDED. THE PATIENT WAS STABLE.
Description of Event or Problem · 0
A ZILIENT GUIDE WIRE WAS UNABLE TO CROSS A CALCIFIED LESION. THE WIRE WAS COMPLETELY UNBRAIDED. THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123057 | ZILIENT | ZILIENT | DQX | CARDIOVASCULAR SYSTEMS, INC | 30G-300-018 | 6512337 | 10852528005602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |