FDA Adverse Event
Malfunction
Summary report: N
ARGON GUIDEWIRE
MDR report key: 1930109
·
Received November 18, 2010
Report
- Report Number
- 1625425-2010-00023
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 6, 2010
- Report Date
- November 18, 2010
- Manufacturer
- ARGON MEDICAL DEVICES, INC.
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT THE END OF THE GUIDEWIRE APPEARED TO HAVE COILED UP ON ITSELF WHEN REMOVING IT FROM THE NEEDLE. CUSTOMER REPORTS THAT ALL PIECES OF THE GUIDEWIRE WERE ACCOUNTED FOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARGON GUIDEWIRE | DQX | ARGON MEDICAL DEVICES, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |