FDA Adverse Event
Injury
Summary report: N
EMERGE?
MDR report key: 23999649
·
Received January 7, 2026
Report
- Report Number
- 2124215-2026-01164
- Event Type
- Injury
- Date Received
- January 7, 2026
- Date of Event
- September 18, 2025
- Report Date
- January 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806394
- PMA / PMN Number
- K113220
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
G4 - PREMARKET: K163174.
Description of Event or Problem · 0
IT WAS REPORTED THAT DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 20MM EMERGE? AND 2.00MM X 30MM EMERGE? BALLOON CATHETER WERE ADVANCED FOR USED. HOWEVER, DURING THE PROCEDURE, A DISTAL DISSECTION WAS OBSERVED. A STENT WAS PLACED AND THE EVENT RESOLVED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59659 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918930200 | 0036912889 | 08714729806394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |