inforMED
MalfunctionGBX

TOTAL ABSCESSION

Received Aug 26, 2021 · Event occurred Jul 19, 2021

Report 12369900 · MDR key 12369900

Device

Generic name

Catheter, Irrigation

Lot number

5674652

Product problems

  • Device Slipped

Patient

23360 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

RETROGRADE NEPHROURETERAL STENT INSERTED, DIFFICULT FORMING PIGTAIL IN RENAL PELVIS. EXTERNAL PLASTIC HUB COVER SLIPPED OFF THE CATHETER AND INTO THE PATIENT'S UROSTOMY AS IT IS NOT ATTACHED TO THE CATHETER OTHERWISE. IT WAS EASILY RETRIEVED WITH A BALLOON CATHETER. ANGIODYNAMICS TOTAL ABSCISSION 14 FR X 45 CM CATHETER, LOT #5674652, ALTHOUGH THIS ISSUE IS NOT SPECIFIC TO THIS LOT OR SIZE.