FDA Adverse Event
Malfunction
Summary report: N
EMERGE¿
MDR report key: 3043087
·
Received April 9, 2013
Report
- Report Number
- 2134265-2013-02033
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 10, 2013
- Report Date
- March 11, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- K113220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AGE AT TIME OF EVENT 18 YEARS OR OLDER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN A SEVERELY TORTUOUS, AND SEVERELY CALCIFIED PORTION OF THE DISTAL RIGHT CORONARY ARTERY. THE 1.50X15MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED AND DURING THE FIRST INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147347 | EMERGE¿ | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493919315150 | 15710402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |