inforMED
InjuryFFE

MAHURKAR DOUBLE LUMEN

Received Feb 27, 2008 · Event occurred Feb 21, 2008

Report MW5005722 · MDR key 1005265

Device

Generic name

Vascath

Catalog number

12 FRENCH 20CM

Lot number

NKQ0214063130

Product problems

  • Material Fragmentation
  • Difficult to Remove
  • Wire(s), breakage of
  • Device, removal of (non-implant)

Patient

62 YR

  • Bleeding
  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional
  • Surgical procedure aborted/stopped
  • Hospitalization required

Narrative

Description of Event or Problem

A PT ADMITTED WITH END STAGE LIVER DISEASE AND CHOLANGITIS AND ACUTE RENAL FAILURE. PLACEMENT OF VASCATH FOR DIALYSIS COMPLICATED BY CATHETER WIRE FRAGMENTING WHEN ATTEMPTING REMOVAL THROUGH CATHETER. THE WIRE COULD NOT BE REMOVED AND ENTIRE PROCEDURE ABORTED AND WHOLE CATHETER REMOVED. LINE COMPLICATION, SECONDARY TO DEVICE MALFUNCTION, RESULTING IN SUBSEQUENT BLEEDING FROM ORIGINAL SITE, AND FURTHER INTERVENTIONS.