FDA Adverse Event
Malfunction
Summary report: N
PATHFINDER PLUS
MDR report key: 21136996
·
Received January 13, 2025
Report
- Report Number
- 21136996
- Event Type
- Malfunction
- Date Received
- January 13, 2025
- Date of Event
- November 13, 2024
- Report Date
- November 27, 2024
- Manufacturer
- UTAH MEDICAL PRODUCTS
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DOCTOR SAID FOR THE LAST MONTH OR SO, THREE OF THE PATHFINDER PLUS BROKE IN THE MIDDLE OF HER CASES. REF: PA701, LOT 1241132. NOTIFIED SUPPLY MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 452544 | PATHFINDER PLUS | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | UTAH MEDICAL PRODUCTS | PA701 | 1241132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |