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

Model Number	M0062251080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code: a0406 captures the reportable event of catheter kinked.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used during a ureteroscopy (urs) procedure performed on (b)(6) 2024.During the procedure, the catheter shows bending damage.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.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used during a ureteroscopy (urs) procedure performed on (b)(6) 2024.During the procedure, the catheter shows bending damage.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of catheter kinked.Block h10: investigation result the returned uromax balloon device was analyzed, and a visual evaluation noted that the balloon was not subjected to positive pressure.No issues were found with the balloon and the tip of the device.A visual and tactile analysis revealed that the shaft of the device to be kinked at more than one location and this damage is consistent with excessive force applied to the device.Additionally, there was no issues found with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.No other issues were noted during analysis.With all the available information, it was confirmed that this is not a new failure type, and the risk is anticipated.There is no evidence of a manufacturing issue or design issue which could have caused the complaint.Additional information was requested with regards to the procedure, patient anatomy and lesion characteristics.No further information is available.The use of this uromax device indicates the requirement for dilation.As the device was used during a ureteroscopy (urs) procedure it is possible that it had an interaction with a stone as the user attempted to position it which would have contributed to the shaft kinks.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: 18882208
• Report Number: 2124215-2024-14289
• Device Sequence Number: 9049421
• 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): 05/07/2024

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: 06/13/2025
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0029586238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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: 48 YR
• Patient Sex: Female