MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number	M0062251010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.Block h11: investigation results the product was not returned for analysis and discarded at the facility therefore technical analysis could not be performed; however, an image was provided by the customer depicting a hair adhered to a piece of surgical tape.With all the available information, boston scientific concludes that the reported event is most likely due to the foreign matter being transferred on to the device from a surgical glove or gown when opening the packaging.Therefore, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was about to be used during a ureteroscopy procedure.Reportedly, upon opening the uromax balloon a hair was found within the sterile package.Additionally, there was no damage found on the packaging.The procedure was completed with another of the same device with no patient complications.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21106900
• Report Number: 2124215-2024-82902
• Device Sequence Number: 18129443
• Product Code: KOE
• UDI-Device Identifier: 08714729341116
• UDI-Public: 08714729341116
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2026
• Device Model Number: M0062251010
• Device Catalogue Number: M0062251010
• Device Lot Number: 0031426212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown