FDA Adverse Event
Injury
Summary report: N
FREECLIMB 70 REPERFUSION SYSTEM
MDR report key: 18944700
·
Received March 20, 2024
Report
- Report Number
- 3016522967-2024-00004
- Event Type
- Injury
- Date Received
- March 20, 2024
- Date of Event
- February 21, 2024
- Report Date
- March 18, 2024
- Manufacturer
- ROUTE 92 MEDICAL, INC.
- Product Code
- NRY
- UDI-DI
- 00853799007497
- PMA / PMN Number
- K223530N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT HAD A LEFT ICA TERMINUS OCCLUSION. A FIRST PASS WITH FREECLIMB 70 REPERFUSION SYSTEM AND SYNCHRO SELECT STANDARD LEFT SOME RESIDUAL CLOT IN THE MID PORTION OF THE M1 SEGMENT. DURING THE SECOND PASS THE DEVICES WERE ADVANCED INTO MID M1 SEGMENT. TENZING 7 AND SYNCHRO WIRE WERE REMOVED AND ASPIRATION WAS PERFORMED THROUGH FREECLIMB 70 FOR ROUGHLY 1-2 MINUTES. FREECLIMB 70 CATHETER WAS RETRACTED INTO THE ZOOM 88 CATHETER AT THE HORIZONTAL PETROUS SEGMENT OF THE LEFT ICA. A CONTRAST INJECTION THROUGH THE ZOOM 88 CATHETER IDENTIFIED EXTRAVASATION AT LEFT M1 SEGMENT. A DISSECTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455311 | FREECLIMB 70 REPERFUSION SYSTEM | PERCUTANEOUS CATHETER | NRY | ROUTE 92 MEDICAL, INC. | 24012403 | 00853799007497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening | FULL LENGTH 070 REPERFUSION SYSTEM |