Description of Event or Problem · 1
PATIENT IN OPERATING ROOM FOR REMOVAL CATHETER FROM RIGHT SUBCLAVIAN. SUTURES AND CATHETER WERE REMOVED BY PHYSICIAN WITHOUT DIFFICULTY. UPON REMOVAL THE CATHETER WAS NOTED TO BE APPROXIMATELY 2.5 TO 3 INCHES LONG, WHICH IS ONLY HALF THE ORIGINAL LENGTH, A CHEST X-RAY WAS IMMEDIATELY DONE WHICH DID REVEAL A PORTION OF CATHETER RETAINED IN THE PATIENT'S CHEST, PROBABLY IN THE PULMONARY ARTERY, ACCORDING TO THE PHYSICIAN'S REPROT. THE PATIENT REQUIRED IMMEDIATE REMOVAL OF THE RETAINED PORTION OF CATHETER UNDER FLUOROSCOPY. PATIENT IS DOING WELL, NO ADVERSE OUTCOME NOTED FROM PROCEDURE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.