FDA Adverse Event
Other
Summary report: N
BARD ACCESS SYSTEMS
MDR report key: 583194
·
Received March 4, 2005
Report
- Report Number
- 583194
- Event Type
- Other
- Date Received
- March 4, 2005
- Date of Event
- February 15, 2005
- Report Date
- March 4, 2005
- Manufacturer
- BARD ACCESS SYSTEM
- Product Code
- DYB
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS UNDER GOING A THROMBOLYSIS TO DECLOT A DIALYSIS THIGH GRAFT. USING A 4 FR COAXIAL MICROINTRODUCER KIT, THE GUIDWIRE (.018") WAS STUCK IN THE LEFT THIGH GRAFT AND BROKE OFF. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS REFERRED TO A SURGEON FOR WIRE EXTRACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD ACCESS SYSTEMS | MICROINTRODUCER KIT | DYB | BARD ACCESS SYSTEM | * | 36JOMA02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |