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

Model Number	M0062251080
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	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was to be used during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During preparation, the balloon expansion did not work.The procedure was completed with another uromax ultra dilation balloon catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.
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 a visual evaluation noted that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Additionally, when the device was attached into an encore inflation unit and positive pressure was applied using di water, a balloon pinhole leak was noted at 18mm proximal from the distal markerband, to its rated burst pressure.A visual and tactile analysis revealed that there were no kinks or damage to the shaft of the device.No other issue noted with the tip of the device.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Based on the available information, it is possible that the device had an interaction with the ureteral stone as the user was attempting to position it causing the pinhole leak in the balloon material, which would also contribute to the to the inflation issue.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.

• 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: 18741415
• Report Number: 2124215-2024-09722
• Device Sequence Number: 6250234
• Product Code: KOE
• UDI-Device Identifier: 08714729341185
• UDI-Public: 08714729341185
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 07/01/2024
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0027602096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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 Age: 70 YR
• Patient Sex: Male