FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE II PRO
MDR report key: 21805029
·
Received April 9, 2025
Report
- Report Number
- 21805029
- Event Type
- Malfunction
- Date Received
- April 9, 2025
- Date of Event
- March 25, 2025
- Report Date
- April 3, 2025
- Manufacturer
- ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
SAPPHIRE BALLOON 1.0 X10 MM BALLOON CAME OFF DELIVERY CATHETER AND WAS PERMANENTLY LODGED IN RPDA [RIGHT POSTERIOR DESCENDING ARTERY].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459805 | SAPPHIRE II PRO | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. | 210-103-5UU | 4231522404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Other |