FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE II PRO
MDR report key: 23736478
·
Received December 8, 2025
Report
- Report Number
- 23736478
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- October 23, 2025
- Report Date
- October 31, 2025
- Manufacturer
- ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
- Product Code
- LIT
- UDI-DI
- 06934955942044
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE 1.0 SAPPHIRE BALLOON RUPTURED WHEN INFLATED IN THE LAD [LEFT ANTERIOR DESCENDING].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157893 | SAPPHIRE II PRO | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. | 210-153-5UU | 4255372506 | 06934955942044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |