Description of Event or Problem · 1
PATIENT SCHEDULED AT OUP PATIENT SURGERY CENTER FOR REVISION OF PORTACULHETA. DURING PROCEDURE PORT REMOVED AND PORTION OF CATHETER NOTED TO BE MISSING. ON FLUOROSCOPY CATHETER NOTED TO BE IN HEART. PATIENT TAKEN TO RECOVERY ROOM FOLLOWING REMOVAL OF MRI PORT AND PORTION OF CATHETER. PHYSICIAN CONFERRED WITH ASSOCIATE THEN ARRANGEMENTS MADE THE REMAINING PORTION OF THE CATHETER TO BE REMOVED IN SPECIAL PROCEDURES IN THE MAIN HOSPITAL. PATIENT TRANSPORTED VIA AMBULANCE TO HOSPITAL AND REMAINING PORTION OF CATHETER WAS REMOVED, AND PATEINT DISCHARGED. CATHETER WAS IMPLANTED 12/8/93.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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: OTHER. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.