FDA Adverse Event
Malfunction
Summary report: N
EMERGE¿
MDR report key: 2834214
·
Received November 15, 2012
Report
- Report Number
- 2134265-2012-06866
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 17, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- K113220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SHAFT BREAK OCCURED. AN EMERGE, MR, US 20 MM X 2.00 MM BALLOON CATHETER WAS BEING LOADED INTO A GUIDE CATHETER WHEN THE SHAFT BROKE AT THE MID PORTION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMERGE¿ | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493918920200 | 14988492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |