FDA Adverse Event
Malfunction
Summary report: N
CLEARWAY RX CATHETER
MDR report key: 3060632
·
Received April 5, 2013
Report
- Report Number
- 1219977-2013-00025
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- August 31, 2012
- Report Date
- March 14, 2013
- Manufacturer
- ATRIUM MEDICAL CORP
- Product Code
- DQY
- PMA / PMN Number
- K061680
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE IS CURRENTLY UNDER EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS WITHOUT ANY DEVIATIONS.
Description of Event or Problem · 1
PRODUCT INSERTED AND ATTEMPTED TO INFUSE. BALLOON WOULD NOT INFLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141725 | CLEARWAY RX CATHETER | DQY | ATRIUM MEDICAL CORP | 80208 | 10787950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |