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

Model Number	M0062251160
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
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 used during a ureteral dilation procedure performed on (b)(6) 2023.During the procedure, the balloon ruptured even though it was inflated to 12 atmospheric pressures (atm) only.The procedure was completed with another uromax ultra dilation balloon catheter device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon ruptured.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used during a ureteral dilation procedure performed on (b)(6) 2023.During the procedure, the balloon ruptured even though it was inflated to 12 atmospheric pressures (atm) only.The procedure was completed with another uromax ultra dilation balloon catheter device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon ruptured.Block h10: investigation result the returned uromax ultra balloon device was analyzed, and a visual evaluation noted that the balloon was not folded indicating that the device was subject to positive pressure.It was also noted that the device was attached to an encore inflation unit.Additionally, positive pressure was applied, and liquid was observed to be leaking from the balloon pinhole located at approximately 25mm proximal of the distal markerband.A visual and tactile analysis revealed that there were no problems found to the shaft, markerband and the tip of the device.Based on the available information, there was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The use of this uromax device suggests the requirement for dilation.The device may have encountered difficult patient anatomy such as stenosis, tortuosity or a ureteral stone which would have contributed to the pinhole in the balloon material.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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18096718
• Report Number: 2124215-2023-61966
• Device Sequence Number: 20186992
• Product Code: KOE
• UDI-Device Identifier: 08714729341246
• UDI-Public: 08714729341246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980795
• 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,Followup
• Report Date (Section B): 11/30/2023

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: 06/09/2025
• Device Model Number: M0062251160
• Device Catalogue Number: 225-116
• Device Lot Number: 0029566001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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