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

Model Number	M0062251270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0504 captures the reportable event of balloon leak.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon was used in the ureter during a transurethral ureterolithotomy procedure performed on (b)(6) 2023.During the procedure, it was noted that the balloon was leaking.The procedure was completed with another uromax ultra balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0504 captures the reportable event of balloon leak.Block h10: investigation result: the returned uromax ultra device was analyzed, and a visual evaluation noted that the balloon was not folded which indicated that the device was subjected to positive pressure.Functional evaluation was performed and the uromax ultra device was attached to an encore inflation unit.Positive pressure was applied and a liquid was observed to be leaking from a pinhole located approximately 24mm proximal of the distal markerband.The tip of the device has no damage.A visual and tactile examination was performed and there were no kinks or damage found to the shaft of the device.No damage was also noticed in both markerbands and was in the correct position on the shaft of the device.No other problems with the device were noted.The reported event was confirmed.It is possible that this failure could have been caused by the balloon interacting with a ureteral stone.Based on the available information and the analysis of the returned device, the most probable root cause of this event is adverse event related to procedure since there is no evidence of a manufacturing issue, design or user problem which could have cause the device problem.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon was used in the ureter during a transurethral ureterolithotomy procedure performed on (b)(6) 2023.During the procedure, it was noted that the balloon was leaking.The procedure was completed with another uromax ultra balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: UROMAX ULTRA KIT
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16855077
• Report Number: 3005099803-2023-02205
• Device Sequence Number: 15146457
• Product Code: KOE
• UDI-Device Identifier: 08714729341345
• UDI-Public: 08714729341345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/07/2023

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: 10/25/2024
• Device Model Number: M0062251270
• Device Catalogue Number: 225-127
• Device Lot Number: 0028795374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG