ARTERIAL CATHETER MINI-KIT 20GA X 6"

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE HAS BEEN RETURNED FOR INVESTIGATION AND IS CURRENTLY IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON THE CLOSURE OF THE INVESTIGATION.

Description of Event or Problem

NURSING NOTE: AROUND 1930 NOTICED ARTERIAL LINE NOT READING, CHECKED SITE AND OOZING BLOOD. UNDER DRESSING SHOWED DISCONNECTED/BROKEN ART LINE CATHETER (CLEAN CUT). SX NOTIFIED. ULTRASOUND SHOWED ~15 CM OF ART LINE SHEATH IN PATIENT L ARM. STILL PERFUSING, PALPABLE PULSES. NEW R RAD ART LINE PLACED. TO OR ~0000 TO REMOVE CATHETER FROM L ARM. OR NOTE: INTRAOPERATIVE FLUOROSCOPY WAS USED TO LOCALIZE THE RADIOPAQUE FOREIGN BODY, MARKING BOTH THE PROXIMAL AND DISTAL EXTENTS OF THE RETAINED ARTERIAL LINE CATHETER AT THE LEVEL OF THE DISTAL RADIUS. THE RADIAL ARTERY COURSE WAS IDENTIFIED AND THE PLANNED INCISION WAS MARKED ALONG THE VOLAR ASPECT OF THE DISTAL LEFT WRIST. A BRUNER INCISION WAS MADE ALONG THE VOLAR-RADIAL ASPECT OF THE DISTAL WRIST OVERLYING THE MARKED FOREIGN BODY. DISSECTION WAS CARRIED THROUGH THE SUBCUTANEOUS TISSUE USING BIPOLAR ELECTROCAUTERY AND TENOTOMY SCISSORS. THE RADIAL ARTERY WAS CAREFULLY IDENTIFIED AND ISOLATED. THE RETAINED CATHETER FRAGMENT WAS PALPABLE WITHIN THE RADIAL ARTERY LUMEN. NO EXTERNAL ARTERIOTOMY OR CUTANEOUS ENTRY SITE FROM THE ORIGINAL ARTERIAL LINE INSERTION WAS VISUALIZED. A LONGITUDINAL ARTERIOTOMY APPROXIMATELY 3¿5 MM IN LENGTH WAS MADE ALONG THE RADIAL ARTERY UNDER LOUPE MAGNIFICATION. THE RETAINED ARTERIAL LINE CATHETER FRAGMENT WAS RETRIEVED THROUGH THE ARTERIOTOMY AND REMOVED IN ITS ENTIRETY AS A SINGLE INTACT PIECE. PHOTOGRAPHS WERE TAKEN TO DOCUMENT COMPLETE REMOVAL. INTRAOPERATIVE FLUOROSCOPY WAS REPEATED AND CONFIRMED NO RESIDUAL RADIOPAQUE FOREIGN BODY REMAINED.