FDA Adverse Event
Malfunction
Summary report: N
Z-MED II CATHETER
MDR report key: 2517970
·
Received April 2, 2012
Report
- Report Number
- 1318694-2012-00007
- Event Type
- Malfunction
- Date Received
- April 2, 2012
- Date of Event
- February 13, 2012
- Report Date
- April 2, 2012
- Manufacturer
- NUMED, INC.
- Product Code
- LIT
- PMA / PMN Number
- K003052
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS EVALUATED AND THE BALLOON BURST AND BALLOON FRAGMENTATION WAS CONFIRMED. ALL PIECES OF THE CATHETER ARE ACCOUNTED FOR. A COMPARATIVE CATHETER WAS PULLED FROM STOCK AND TESTED FOR RATED BURST PRESSURE. THE CATHETER BURST AT 17 ATM, WHICH IS ABOVE THE LABELED RBP OF 10 ATM. IT STATES IN THE REPORT THAT THIS DEVICE WAS BEING USED TO REDILATE A PREVIOUSLY PLACED GENESIS XD STENT. THIS IS AN OFF LABEL INDICATION. THIS CATHETER IS APPROVED FOR A PTV INDICATION.
Description of Event or Problem · 1
BALLOON RUPTURED DURING PROCEDURE. SURGERY FOR REMOVAL OF BALLOON FRAGMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Z-MED II CATHETER | PTV CATHETER | LIT | NUMED, INC. | 305 | ZZ-5487 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |