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

Model Number	M0062251040
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable investigation result of balloon pinhole.Block h10: investigation results: the returned uromax ultra device was analyzed, and visual evaluation noted that the balloon was not folded, which is an indicative that the balloon was subjected to positive pressure.Additionally, a pinhole was identified at the distal markerband.The rated burst pressure of this device was at 20 atmospheres.Also, it was revealed that the shaft of the device was kinked at several locations.No issues noted with the tip or markerbands of the device; both markerbands were undamaged and in the correct position on the shaft.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Based on the available information, the puncture in the balloon probably occurred due to interaction with the kidney stone.The unavailability to inflate the device was most likely caused by the identified pinhole.The shaft kinks noted during device analysis could have occurred due to an interaction between the user and the device.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint and there is no evidence that the device failed to meet uromax upgrade specification.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a ureteroscopy (urs) procedure.During the procedure the balloon was inserted and attempted to inflate; however, the balloon would not inflate.The procedure was completed with another of the same device with no patient complications.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

• 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: 19160673
• Report Number: 2124215-2024-24223
• Device Sequence Number: 7330416
• Product Code: KOE
• UDI-Device Identifier: 08714729341147
• UDI-Public: 08714729341147
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: 03/28/2025
• Device Model Number: M0062251040
• Device Catalogue Number: 225-104
• Device Lot Number: 0029132914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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