FDA Adverse Event
Malfunction
Summary report: N
AQUATRACK HYDROPHILIC GUIDEWIRE
MDR report key: 1935779
·
Received December 3, 2010
Report
- Report Number
- 1625425-2010-00026
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- July 13, 2010
- Report Date
- November 10, 2010
- Manufacturer
- ARGON MEDICAL DEVICES, INC.
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORTER INDICATED THAT DEVICE IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
DURING HEART CATHETERIZATION END OF WIRE SHEARED OFF WHILE BEING PULLED BACK THROUGH NEEDLE. THIS RESULTED IN FOREIGN BODY LEFT BEHIND IN SUBCUTANEOUS TISSUE OF RIGHT LEG. PHYSICIAN STATES PROCEDURE WAS ABORTED SECONDARY TO BILATERAL ILIAC DISEASE AND UNABLE TO PASS THROUGH/ADVANCE PROXIMATELY. PHYSICIAN STATES HE FEELS THAT THE RISKS OF ANY SURGICAL INTERVENTION IS GREATER FOR THE PT THAN LEAVING THE WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUATRACK HYDROPHILIC GUIDEWIRE | AQUATRACK GUIDEWIRE | DQX | ARGON MEDICAL DEVICES, INC. | C3518-RSA | 80000683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |