FDA Adverse Event
Malfunction
Summary report: N
NEPHROMAX
MDR report key: 24933158
·
Received April 20, 2026
Report
- Report Number
- 2124215-2026-21373
- Event Type
- Malfunction
- Date Received
- April 20, 2026
- Date of Event
- March 25, 2026
- Report Date
- May 15, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LJE
- UDI-DI
- 08714729012641
- PMA / PMN Number
- K121614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF PINHOLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A TINY HOLE IN THE BALLOON PART, SO IT DOES NOT EXPAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224206 | NEPHROMAX | CATHETER, NEPHROSTOMY | LJE | BOSTON SCIENTIFIC CORPORATION | M0062101170 | 0032337022 | 08714729012641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |