FDA Adverse Event
Injury
Summary report: N
FLEX VESSEL PREP SYSTEM
MDR report key: 23689052
·
Received December 1, 2025
Report
- Report Number
- 3012696653-2025-00005
- Event Type
- Injury
- Date Received
- December 1, 2025
- Date of Event
- October 30, 2025
- Report Date
- December 1, 2025
- Manufacturer
- VENTUREMED GROUP, INC.
- Product Code
- PNO
- UDI-DI
- 00863656000325
- PMA / PMN Number
- K202187
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
VESSEL DISSECTION NOTED BY PHYSICIAN LEADING TO FURTHER INTERVENTIONAL PROCEDURES TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2736611 | FLEX VESSEL PREP SYSTEM | PERIPHERAL INTRAVASCULAR CATHETER | PNO | VENTUREMED GROUP, INC. | FSC 4-75 | 65718 | 00863656000325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |