FDA Adverse Event
Malfunction
Summary report: N
EMERGE?
MDR report key: 22631008
·
Received July 28, 2025
Report
- Report Number
- 2124215-2025-50471
- Event Type
- Malfunction
- Date Received
- July 28, 2025
- Date of Event
- June 29, 2025
- Report Date
- July 28, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806196
- PMA / PMN Number
- K113220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
G4: PREMARKET - K163174.
Description of Event or Problem · 0
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING THE PROCEDURE, A 2.00MM X 15MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTICED THAT A FEW CENTIMETERS FROM THE SHEATH, THE DELIVERY SHAFT WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1455574 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918915200 | 0035215336 | 08714729806196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |