ARROW RA CATH SET: 20 GA X 1-3/4IN

Description of Event or Problem

IT WAS REPORTED "DURING THE PROCEDURE, A PORTION OF THE CATHETER BROKE OFF WITHIN THE PATIENT'S RADIAL ARTERY. THE OPERATING SURGEON WAS IMMEDIATELY NOTIFIED, AND A VASCULAR SURGERY CONSULT WAS OBTAINED. ULTRASOUND IMAGING WAS PERFORMED, AND THE RETAINED CATHETER FRAGMENT WAS VISUALIZED WITHIN THE PATIENT'S RADIAL ARTERY". THERE WAS NO PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED STATES "THE CATHETER FRAGMENT REMAINS IN SITU, AND THE VASCULAR SURGERY TEAM IS ACTIVELY FOLLOWING AND MANAGING THE PATIENT".

Additional Manufacturer Narrative

QN #: (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED "DURING THE PROCEDURE, A PORTION OF THE CATHETER BROKE OFF WITHIN THE PATIENT'S RADIAL ARTERY. THE OPERATING SURGEON WAS IMMEDIATELY NOTIFIED, AND A VASCULAR SURGERY CONSULT WAS OBTAINED. ULTRASOUND IMAGING WAS PERFORMED, AND THE RETAINED CATHETER FRAGMENT WAS VISUALIZED WITHIN THE PATIENT'S RADIAL ARTERY". THERE WAS NO PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED STATES "THE CATHETER FRAGMENT REMAINS IN SITU, AND THE VASCULAR SURGERY TEAM IS ACTIVELY FOLLOWING AND MANAGING THE PATIENT".