FDA Adverse Event
Injury
Summary report: N
RA CATH SET: 20 GA X 1-3/4"
MDR report key: 2193549
·
Received October 4, 2007
Report
- Report Number
- 9680794-2007-00014
- Event Type
- Injury
- Date Received
- October 4, 2007
- Date of Event
- August 23, 2007
- Report Date
- October 5, 2007
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A F/U REPORT WILL BE FILED IF MORE INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT WITH HISTORY OF HYPERTENSION WAS BROUGHT IN BY AMBULANCE FOR RIGHT MYOCARDIAL INFARCTION, WITH TPA ADMINISTERED IN EMERGENCY DEPT. SYMPTOMS IMPROVED AND PT WAS TRANSFERRED TO ICU. THE FOLLOWING DAY AN ARTERIAL LINE WAS INSERTED. AT TIME OF PLACEMENT, WHEN TRYING TO SUTURE AROUND HUB OF CATHETER, THE CATHETER SNAPPED LEAVING CATHETER TIP INSIDE ARTERY. A VASCULAR SURGEON WAS CALLED STAT AND A CUT DOWN ATTEMPTED WHICH WAS UNSUCCESSFUL IN REMOVING CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RA CATH SET: 20 GA X 1-3/4" | RADIAL ARTERY PRODUCTS | DQX | ARROW INTERNATIONAL, INC. | NA | CF7037360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | INPATIENT ACUTE REHABILITATION| TPA |