FDA Adverse Event
Malfunction
Summary report: N
RA CATH SET: 20 GA X 1-1 /2
MDR report key: 2192799
·
Received July 20, 2011
Report
- Report Number
- 9680794-2011-00046
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- May 19, 2011
- Report Date
- July 13, 2011
- Manufacturer
- ARROW INTERNACIONAL INC
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN RETRACTING THE SPRING WIRE GUIDE (SWG) FROM THE (B)(6) FEMALE PT IN THE INTENSIVE CARE UNIT, RESISTANCE WAS FELT AND THE SWG BEGAN TO KINK AND "CURL." THE SWG WAS SUCCESSFULLY REMOVED IN ITS ENTIRETY AND AT THAT TIME, FRACTURE POINTS WERE NOTED ON THE CANNULA. A SECOND SET WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE INSERTION SITE WAS THE RIGHT RADIAL ARTERY AND AN ULTRASOUND WAS DONE TO CHECK FOR PERIPHERAL PERFUSION. ADD'L INFO RECEIVED ON 7/5/2011 FROM THE DISTRIBUTOR STATED THAT THE SWG DID UNRAVEL/SEPARATE AND NO PIECES WERE LEFT BEHIND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RA CATH SET: 20 GA X 1-1 /2 | RADIAL ARTERY PRODUCTS | DQX | ARROW INTERNACIONAL INC | CF9042775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |