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

Model Number	M0062251000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the complaint device found that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Functional evaluation was performed by attaching the device into an encore inflation unit, the balloon was inflated a leak was noted due to a pinhole located at the proximal section of the balloon.Examination of the balloon material and proximal markerband identified no issues which could have potentially contributed to this complaint.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon was used in the kidney, ureter and bladder (kub) during an ureteroscopy (urs) procedure performed on (b)(6) 2019.According to the complainant, during introduction of the device into the patient, it was noted that the balloon had a leak.The procedure was completed with another uromax ultra dilatation balloon.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 okay.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9081285
• Report Number: 3005099803-2019-04627
• Device Sequence Number: 2752629
• Product Code: EZN
• UDI-Device Identifier: 08714729341109
• UDI-Public: 08714729341109
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 07/30/2021
• Device Model Number: M0062251000
• Device Catalogue Number: 225-100
• Device Lot Number: 0022447572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1