UROMAX ULTRA KIT
Received Oct 31, 2025 · Event occurred Aug 5, 2025
Report 2124215-2025-78201 · MDR key 23441965
Device
Generic name
Dilator, Catheter, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0062251370Catalog number
225-137
Lot number
0035536689
Product problems
- Material Rupture
- Device Contamination with Chemical or Other Material
- Material Rupture
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE THIRD OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.
Additional Manufacturer Narrative
H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN PRESENT IN THE DEVICE.