FDA Adverse Event
Malfunction
Summary report: N
MULLINS-X CATHETER
MDR report key: 1707160
·
Received May 25, 2010
Report
- Report Number
- 1318694-2010-00002
- Event Type
- Malfunction
- Date Received
- May 25, 2010
- Date of Event
- April 19, 2010
- Report Date
- May 25, 2010
- Manufacturer
- NUMED, INC.
- Product Code
- DQY
- PMA / PMN Number
- K022722
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE WAS BEING USED OFF LABEL FOR AN UNAPPROVED INDICATION. THIS DEVICE IS LABELED AND 510(K) CLEARED FOR A PTA INDICATION. THE DEVICE WAS NOT RETURNED TO NUMED FOR EVALUATION AND THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE FROM THE FACILITY. THE PHYSICIAN STATED THAT THERE WERE MULTIPLE BALLOON RUPTURES SECONDARY TO SIGNIFICANT CALCIFICATION OF THE CONDUIT.
Description of Event or Problem · 1
POST DILATATION OF A STENT, THE BALLOON RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULLINS-X CATHETER | PTA CATHETER | DQY | NUMED, INC. | 250X | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |