Description of Event or Problem · 0
ACCORDING TO THE LITERATURE ARTICLE, A RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED AT A LARGE UNIVERSITY HOSPITAL BETWEEN JANUARY 2017 AND OCTOBER 2024 IN A SURGICAL SETTING USING SIX MOBILE SURGICAL C-ARM FLUOROSCOPY UNITS. THE STUDY INCLUDED ALL PEDIATRIC PATIENTS (<19 YEARS) UNDERGOING FLUOROSCOPY-GUIDED CVC INSERTION PROCEDURES, WITH THE IRRADIATED FIELD INVOLVING THE THORACIC REGION AND THE REGION CLOSE TO THE NECK (PATIENT¿S ANATOMY), AS PER CLINICAL INDICATIONS. ELIGIBLE PROCEDURES INVOLVED THE PLACEMENT OF LONG-TERM VENOUS ACCESS DEVICES SUCH AS HICKMAN, BROVIAC, PERMCATH, AND DOUBLE-LUMEN CATHETERS. PORT-A-CATHS AND PERIPHERALLY INSERTED CENTRAL CATHETERS (PICCS) WERE EXCLUDED DUE TO DIFFERING INSERTION TECHNIQUES AND CLINICAL INDICATIONS. AMONG THE STUDY POPULATION 59.02% WERE MALE AND 40.98% WERE FEMALE. THE MEAN AGE WAS FOUR YEARS, RANGING FROM 25 DAYS TO 18 YEARS. THE MEAN WEIGHT WAS 18.41 KG, RANGING FROM 2.195 TO 108.5 KG. IN TOTAL, THE 832 CVC FGI (FLUOROSCOPY-GUIDED CENTRAL VENOUS CATHETER) PROCEDURE WERE PERFORMED ON A COHORT OF 510 PATIENTS, THIS INDICATES THAT MANY PATIENTS UNDERWENT MULTIPLE CVC INSERTIONS/REPLACEMENT DURING HOSPITALIZATION, OFTEN DUE TO ACCESS LOSS, LOCAL INFLAMMATION, OR OTHER COMPLICATIONS WHICH IS A TYPICAL SCENARIO IN CHILDREN WITH CHRONIC DISEASES OR UNDERGOING PROLONGED TREATMENTS. REFERENCE REPORT#: MW5185388. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).