FDA Adverse Event
Death
Summary report: N
CVC SET: 2-LUMEN 7 FR X 20 CM
MDR report key: 4891743
·
Received July 6, 2015
Report
- Report Number
- 9680794-2015-00095
- Event Type
- Death
- Date Received
- July 6, 2015
- Date of Event
- April 21, 2015
- Report Date
- June 25, 2015
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
QN#(B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN UTI DURING REMOVAL OF THE GUIDE WIRE FROM THE PATIENT'S RIGHT SUBCLAVIAN VEIN, THE GUIDE WIRE BROKE AND A PIECE REMAINED IN THE PATIENT. AS A RESULT, SURGICAL AND RADIOLOGY INTERVENTION WERE NECESSARY. PER THE DOCTOR, THE PIECE OF GUIDE WIRE THAT REMAINED IN THE PATIENT WAS BELIEVED TO HAVE CONTRIBUTED TO THE PATIENT SEPSIS WHICH RESULTED IN THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435891 | CVC SET: 2-LUMEN 7 FR X 20 CM | ADULT MULTI LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. | 14F14A0277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Death |