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	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of catheter leak.Block h10: investigation result.The returned uromax balloon device was analyzed, and the balloon was not folded which indicates that the device was subjected to positive pressure.It was also noted a balloon pinhole located approximately 9mm proximal of the distal markerband and the rated burst pressure of this device was at 20 atmospheres.There was no damage found on the tip and shaft of the device.Additionally, no issues found on the markerbands.Both markerbands were undamaged and in the correct position of the shaft of the device.With all the available information, the investigation found that this is not a new failure type, and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.This device was used during retrograde intrarenal surgery (rirs) to treat kidney stones.The pinhole in the balloon material most probably occurred due to an interaction between the balloon and the kidney stones during the procedure.Therefore, the most probable caused is adverse event related to patient condition.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a retrograde intrarenal surgery (rirs) procedure.During the procedure, the contrast media was leaked from the balloon catheter.The procedure was completed with another of the same device with no patient complications.Analysis of the returned device identified a pinhole in the catheter.

• 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: 19243678
• Report Number: 2124215-2024-26826
• Device Sequence Number: 17891780
• 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
• Report Date (Section B): 05/03/2024

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: 07/01/2024
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0027602096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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: 70 YR
• Patient Sex: Female