MalfunctionLJE
NEPHROMAX KIT
Received Jun 15, 2026 · Event occurred May 20, 2026
Report 2124215-2026-31791 · MDR key 25508393
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Product code (LJE)
Manufacturer (Boston Scientific Corporation)
Model (M0062101620)
Device
Generic name
Catheter, Nephrostomy
Manufacturer
Boston Scientific CorporationModel number
M0062101620Catalog number
M0062101620
Lot number
0037373831
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A1801 CAPTURES THE REPORTABLE EVENT OF CONTAMINATION.
Description of Event or Problem
IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, A SMUDGED WAS FOUND ON THE CATHETER BUT STARTED COMING OFF WHEN WIPING. REPORTEDLY, THE DEVICE HAD NO MALFUNCTION; HOWEVER, IT WAS FOUND TO BE CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.