FDA Adverse Event
Malfunction
Summary report: N
MYNX CADENCE
MDR report key: 2417720
·
Received January 3, 2012
Report
- Report Number
- 2417720
- Event Type
- Malfunction
- Date Received
- January 3, 2012
- Date of Event
- December 19, 2011
- Report Date
- January 3, 2012
- Manufacturer
- ACCESS CLOSURE INC.
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE DOCTOR WAS USING THE MYNX DEVICE TO GAIN HEMOSTASIS OF THE FEMORAL ARTERY. WHEN DEPLOYING THE VASCULAR PLUG, THE DEVICE WAS MISSING ITS PLUG ADVANCER. THE PIECE THAT WAS MISSING IS THE WHITE SHAFT THAT IS USED TO HOLD THE PLUG ON AN ARTERY WHEN THE BALLOON AND THE DEVICE IS REMOVED. MANUAL COMPRESSION WAS USED FOR 20 MINUTES TO OBTAIN HEMOSTASIS. THERE WAS NO CHANGE IN THE PATIENT'S OUTCOME DUE TO THE DEVICE FAILURE. WE HAVE OTHER DEVICES FROM THE SAME LOT, BUT NONE OF THE OTHER DEVICES USED HAVE HAD PIECES MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MYNX CADENCE | DEVICE, HEMOSTASIS, VASCULAR | MGB | ACCESS CLOSURE INC. | * | F1125203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | NO OTHER THERAPIES |