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

Model Number	M0062251080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the right ureter during an ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was leaking contrast.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak.Block h10: investigation result: the returned uromax ultra balloon was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was returned attached to an encore inflation unit.Functional evaluation was performed by applying positive pressure, and it was observed that the balloon was leaking due to a pinhole located at the proximal of the distal markerband.A visual and tactile examination revealed that there were no problems found on the shaft and the tip of the device.A visual examination was also performed to the markerbands, and no problems were observed.Additionally, both markerbands are in the correct position on the shaft of the device.No other problems with the device were noted.The reported event of balloon leak was confirmed.It is possible that the interaction between the balloon and ureteral stone could have caused the pinhole found in the balloon material.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the right ureter during an ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was leaking contrast.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16003424
• Report Number: 3005099803-2022-07430
• Device Sequence Number: 6577828
• 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,Followup
• Report Date (Section B): 02/21/2023

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: 10/30/2024
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0028299913
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2021
• 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 Sex: Male