UMBILICAL CATHETER
Received Apr 16, 2015 · Event occurred Feb 14, 2015
Report 2245270-2015-00035 · MDR key 4702519
Device
Generic name
Catheter, Umbilical Artery, Fos
Manufacturer
Vygon Corp.Model number
270.03Lot number
270814FQ
Product problems
- Material Fragmentation
Patient
Not reported
- Death
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO VYGON FOR EVALUATION BUT THE EVENTS WILL BE PART OF COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
Description of Event or Problem
PRETERM MALE INFANT, (B)(6) OLD, HOSPITALIZED IN NEONATAL UNIT. IT WAS DECIDED TO USE A 3.5 FR UMBILICAL CATHETER TO TAKE GAS VENOUSLY, BUT WHEN RESPIRATORY THERAPY STAFF TRIED THE CATHETER DID NOT RETURN. X-RAY WAS TAKEN TO SHOW THE POSITION OF THE CATHETER. IT WAS DECIDED TO REMOVE THE CATHETER, AND IT BURST DURING REMOVAL. REPEATED ATTEMPTS TO REMOVE THE CATHETER TIP, BUT WAS UNSUCCESSFUL. X-RAY TAKEN SHOWED CATHETER SHIFTED TO PULMONARY VEIN. IT WAS NECESSARY TO CARDIOVID CLINICAL REMISSION FOR HEMODYNAMICS EXTRACTION PROCEDURE AND RETURN TO INSTITUTION. THE PATIENT DIED DURING CATHETERIZATION AT THAT INSTITUTION.