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

Model Number	M0062251010
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the returned complaint device found the device was attached to the encore inflation unit.The balloon was not folded which indicates that the device was subjected to positive pressure.Blood was observed within the balloon which indicates there is evidence of a device leak.In addition, visual, tactile and microscopic analysis were performed to the catheter, tip and markerband, and no damages were found.Functional evaluation was performed.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal markerband.The balloon material and the distal markerbands identified no issues which could potentially have contributed to the complaint.Based upon the information provided and the condition of the device returned for analysis, the most probable root cause is adverse event related to patient condition.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 instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter was used during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, there was an air leak noticed in the catheter of the device.It was reported that the device was removed and the procedure was completed with another uromax ultra dilation balloon catheter.There were no patient complications reported as a result of this event, and the patient's condition following the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

• 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: 12525694
• Report Number: 3005099803-2021-05014
• Device Sequence Number: 1547838
• Product Code: KOE
• UDI-Device Identifier: 08714729341116
• UDI-Public: 08714729341116
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 09/02/2022
• Device Model Number: M0062251010
• Device Catalogue Number: 225-101
• Device Lot Number: 0024364818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1