FDA Adverse Event
Injury
Summary report: N
XPRESS-WAY RX CATHETER, 6FR
MDR report key: 6251140
·
Received January 13, 2017
Report
- Report Number
- 3011175548-2017-00001
- Event Type
- Injury
- Date Received
- January 13, 2017
- Date of Event
- December 19, 2016
- Report Date
- December 28, 2016
- Manufacturer
- KANEKA PHARMA AMERICA LLC
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE REPORT RECEIVED STATED THAT THE X-PRESSWAY DEVICE FILTER WAS CLOGGED. THE ASPIRATE SAT IN THE FILTER. IT REMAINED CLOGGED EVEN AFTER SQUIRTING WITH HEPARINIZED SALINE.
Description of Event or Problem · 1
THE REPORT RECEIVED STATED THAT THE X-PRESSWAY DEVICE FILTER WAS CLOGGED. THE ASPIRATE SAT IN THE FILTER. IT REMAINED CLOGGED EVEN AFTER SQUIRTING WITH HEPARINIZED SALINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33576 | XPRESS-WAY RX CATHETER, 6FR | CATHETER, EMBOLECTOMY, | DXE | KANEKA PHARMA AMERICA LLC | T2R6SA4A | KPO76557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |