FDA Adverse Event Injury Summary report: N

ARTERIAL RADIAL CATHETER KIT

MDR report key: 1862202 · Received October 4, 2010

Report

Report Number
1862202
Event Type
Injury
Date Received
October 4, 2010
Date of Event
September 22, 2010
Report Date
October 1, 2010
Manufacturer
ARROW INTERNATIONAL, INC.
Product Code
DQY
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PATIENT IS AN (B)(6) FEMALE, ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2010. SHE HAS A DIAGNOSIS OF CEREBRAL ARTERIOVENOUS MALFORMATION (AVM). SHE HAS HAD COMPLICATIONS FROM A CEREBRAL HEMORRHAGE THAT OCCURRED AROUND (B)(6) 2010. SHE WAS ADMITTED FOR SURGERY TO REMOVE FLUID THAT HAD COLLECTED IN THE BACK OF HER BRAIN. THE ANESTHESIOLOGY ATTENDING REPORTED THAT DURING THE ATTEMPT TO PLACE AN ARROW 20 GAUGE RADIAL ARTERY CATHETER THE GUIDE WIRE BROKE OFF IN THE PATIENT'S ARM DURING INSERTION. THERE WAS DIFFICULTY FEEDING THE CATHETER AND WHEN THE CATHETER AND WIRE WERE REMOVED THE WIRE SNAGGED IN THE TISSUE. PLASTICS WERE INFORMED, AND ANOTHER SURGEON ARRIVED TO REMOVE THE BROKEN WIRE. THE WIRE WAS RETRIEVED BY A 1.5 CM INCISION MADE LONGITUDINALLY OVER THE RADIAL ARTERY. THE WIRE WAS TRACED DOWN AND APPEARED TO ENTER INTO THE RADIAL ARTERY IN THE MID-POINT OF THE ARTERY. THERE WAS A HOLE ON THE SURFACE OF THE RADIAL ARTERY, WHICH WAS REPAIRED USING AN INTERRUPT 7-0 SUTURE. AN X-RAY WAS PERFORMED AT THE END OF THE PROCEDURES TO INSURE THERE WAS NO REMNANT OF THE WIRE LEFT BEHIND AND THE X-RAY WAS CLEAR. THE PATIENT TOLERATED THE PROCEDURE WELL. BOTH PROCEDURES WERE COMPLETED AND NO COMPLICATIONS ARE EXPECTED AS RESULT OF THE BROKEN GUIDE WIRE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARTERIAL RADIAL CATHETER KIT AR CATHETER KIT DQY ARROW INTERNATIONAL, INC. RA-04020 CF0043843
2 ARTERIAL RADIAL CATHETER KIT AR CATHETER KIT DQY ARROW INTERNATIONAL, INC. CF0058387

Patients

Seq Age Sex Outcome Treatment
1 18 YR Required Intervention