FDA Adverse Event
Summary report: N
TRANSITIONLESS MICROPUNCTURE INTRODUCER SET, STAINLESS STEEL
MDR report key: 1983495
·
Received January 21, 2011
Report
- Report Number
- 1983495
- Date Received
- January 21, 2011
- Date of Event
- December 23, 2010
- Report Date
- January 21, 2011
- Manufacturer
- COOK
- Product Code
- DQX
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING NEEDLE STICK TO ACCESS RIGHT FEMORAL ARTERY, MD WAS UNABLE TO ACCESS ARTERY, THE WIRE BECAME LODGED AND WAS REMOVED WITH DIFFICULTY. DISTAL END OF THE WIRE LOOKED CURLED AND WAS BELIEVED TO BE INTACT AND PLACED ON PROCEDURE TABLE. MD WAS THEN ABLE TO ACCESS ARTERY WITH PERCUTANEOUS NEEDLE AND INSERT COPE MANDRIL WIRE WITHOUT RESISTANCE. PROCEDURE WAS COMPLETED SUCCESSFULLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DISTAL END OF WIRE LOOKED CURLED AND WAS BELIEVED TO BE INTACT AND PLACED ON PROCEDURE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSITIONLESS MICROPUNCTURE INTRODUCER SET, STAINLESS STEEL | WIRE, GUIDE, CATHETER | DQX | COOK | 99999346 | 2603991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |