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	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation a uromax ultra dilation balloon catheter device was found bent.No further information was reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of catheter kinked.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of catheter kinked.Nvestigation result: the returned uromax ultra balloon device was analyzed, and a visual evaluation noted that the balloon was not subjected to positive pressure.Additionally, no issues were noted with the balloon and the tip of the device.A visual and tactile analysis was performed to the shaft of the device and noticed a kinked at approximately 75mm proximal of the proximal markerband.A visual examination was performed on the markerbands and found no issues.Both the markerbands were undamaged and in the correct position on the shaft of the device.Based on the available information, the reported problem is most likely due to handling of the device during preparation for the procedure which could have possible affected the device performance and its intended purpose.Therefore, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported that during preparation a uromax ultra dilation balloon catheter device was found bent at the end of the balloon where it was rolled up.The procedure was completed with another of the same device with no patient complications.

• 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: 20141069
• Report Number: 2124215-2024-54673
• Device Sequence Number: 12633039
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 04/16/2026
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0031439579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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