FDA Adverse Event
Malfunction
Summary report: N
NEPHROMAX KIT
MDR report key: 24613370
·
Received March 16, 2026
Report
- Report Number
- 2124215-2026-14505
- Event Type
- Malfunction
- Date Received
- March 16, 2026
- Date of Event
- February 13, 2026
- Report Date
- March 16, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LJE
- UDI-DI
- 08714729077589
- PMA / PMN Number
- K121614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(6). BLOCK H6: DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF BALLOON PINHOLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE AND FOUND THAT IT HAD A PINHOLE. 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 |
|---|---|---|---|---|---|---|---|
| 674759 | NEPHROMAX KIT | CATHETER, NEPHROSTOMY | LJE | BOSTON SCIENTIFIC CORPORATION | M0062101180 | 0033432494 | 08714729077589 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |