FDA Adverse Event
Injury
Summary report: N
RA CATH SET: 22 GA X 1-3/8
MDR report key: 3202105
·
Received June 27, 2013
Report
- Report Number
- 9680794-2013-00032
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- May 3, 2013
- Report Date
- June 26, 2013
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WILL NOT BE RETURNED.
Description of Event or Problem · 1
THIS COMPLAINT WAS RECEIVED VIA MAUDE EVENT REPORT. IT WAS REPORTED THAT DURING CRANIAL VAULT RECONSTRUCTION, THE PHYSICIAN WANTED ARTERIAL ACCESS. THE CATHETER WAS PLACED IN THE PATIENT'S LEFT WRIST. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE, IT CAME APART. THEY THOUGHT THEY REMOVED ALL PIECES. AT THE END OF THE PROCEDURE, THEY PERFORMED X-RAYS. ONE SHOWED A METAL PIECE IN THE PATIENT'S LEFT WRIST. THE SURGEON WENT IN AND REMOVED A SMALL PIECE OF WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291820 | RA CATH SET: 22 GA X 1-3/8 | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTERNATIONAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |