FDA Adverse Event
Malfunction
Summary report: N
FREECLIMB 70 REPERFUSION SYSTEM
MDR report key: 20656752
·
Received November 11, 2024
Report
- Report Number
- 3016522967-2024-00006
- Event Type
- Malfunction
- Date Received
- November 11, 2024
- Date of Event
- June 14, 2024
- Report Date
- July 12, 2024
- Manufacturer
- ROUTE 92 MEDICAL, INC.
- Product Code
- NRY
- UDI-DI
- 00853799007541
- PMA / PMN Number
- K223530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT WAS SUFFERING FROM A STROKE WITH THE RIGHT INTERNAL CAROTID ARTERY BLOCKED. PHYSICIAN ADVANCED FREE CLIMB 70 UP INTO THE RICA AND BROUGHT IT TO M1 SEGMENT WITHOUT ANY ISSUE. AFTER CONNECTING THE ASPIRATION THE PHYSICIAN FELT RESISTANCE PULLING BACK THE CATHETER. THE PHYSICIAN COMPLETELY REMOVED THE SYSTEM FROM THE PATIENT AND FOUND THE CATHETER HAD UNRAVELED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257443 | FREECLIMB 70 REPERFUSION SYSTEM | PERCUTANEOUS CATHETER | NRY | ROUTE 92 MEDICAL, INC. | 24051309 | 00853799007541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | FREECLIMB 70 SYSTEM |