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	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 dilation balloon catheter device was used in the ureter during a transurethral ureterolithotomy procedure performed on (b)(6) 2023.During the procedure, the pressure could not reach, and the balloon was leaking liquid.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 stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak.Block h10: investigation result a visual examination of the returned device found that the balloon was not folded which indicated that the device was subjected to positive pressure.It was also noted that the device was attached to an encore inflation unit and positive pressure was applied when liquid was leaking from a balloon pinhole located at the distal markerband.The rated burst pressure of this device as per uromax upgrade specification is 20 atmospheres.A visual and tactile examination revealed no kinks or damage to the shaft.Additionally, a visual examination was observed and no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.Based on the available information, it is possible that the factors encountered during the procedure and difficult patient anatomy could have caused the balloon to tear.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used in the ureter during a transurethral ureterolithotomy procedure performed on (b)(6) 2023.During the procedure, the pressure could not reach, and the balloon was leaking liquid.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 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: 17599139
• Report Number: 3005099803-2023-04548
• Device Sequence Number: 7570263
• 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): 10/02/2023

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: 02/10/2025
• Device Model Number: M0062251270
• Device Catalogue Number: 225-127
• Device Lot Number: 0030503426
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 76 KG