FDA Adverse Event
Malfunction
Summary report: N
EV3
MDR report key: 1603589
·
Received February 8, 2010
Report
- Report Number
- 1603589
- Event Type
- Malfunction
- Date Received
- February 8, 2010
- Date of Event
- January 6, 2010
- Report Date
- February 2, 2010
- Manufacturer
- EV3 INC.
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
WHILE IN USE, THE BALLOON WOULD NOT STAY INFLATED; IT KEPT DEFLATING. IT WAS FELT THAT THE BALLOON HAD A LEAK. IT WOULD NOT REMAIN INFLATED TO FINISH PROCEDURE. ANOTHER DEVICE HAD TO BE OPENED TO FINISH THE PROCEDURE. UPON INSPECTION OF THE DEVICE, IT APPEARED THAT THE STENT THAT IS IN THE CENTER OF THE BALLOON WAS CRACKED/BENT WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO HARM OTHER THAN DELAY IN COMPLETING THE PROCEDURE WHILE ANOTHER DEVICE WAS OPENED. THE MANUFACTURER REQUESTED THE DEVICE BE SENT TO THEM FOR ANALYSIS, AND WILL SEND A BIOKIT FOR SHIPPING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EV3 | CATHETER, PERCUTANEOUS | DQY | EV3 INC. | AB35W05120135 | 7742604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |