FDA Adverse Event
Injury
Summary report: N
SPRING WIRE GUIDE COMPONENT
MDR report key: 1063465
·
Received June 20, 2008
Report
- Report Number
- 1036844-2008-00101
- Event Type
- Injury
- Date Received
- June 20, 2008
- Date of Event
- April 9, 2008
- Report Date
- June 20, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQX
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED BY MEDWATCH REPORT THAT WHILE ATTEMPTING TO REMOVE RIGHT FEMORAL ARTERIAL LINE (AFTER BLOOD RETURN) THE SPRING WIRE GUIDE (SWG) WAS ADVANCED INTO THE ARTERY AND THEN THE CATHETER WAS ADVANCED OVER THE SWG. THE ARTERIAL SWG BECAME UNRAVELED. X-RAYS AND ULTRASOUND REVEALED THE SWG WAS STILL IN THE PT. AS A RESULT, WITH EFFORT, THE SWG WAS COMPLETELY PULLED OUT OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRING WIRE GUIDE COMPONENT | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQX | ARROW INTL., INC. | CF8012486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |