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

Model Number	M0062251210
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon has a pinhole located at the proximal of the distal markerband, thereby confirming the reported event of balloon unable to inflate.Further examination was performed to the balloon material and markerbands and no damages were noted.A visual and tactile analysis were performed to the tip and the catheter shaft, and no damages or problems were found that could potentially have contributed to the reported event.It is possible that the interaction between the balloon and the kidney stone could have caused the found problem of balloon pinhole, resulting to the balloon inflation problem.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instruction 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 procedure performed on (b)(6) 2021.During the procedure, the balloon would not inflate.The procedure was completed with another uromax ultra dilation balloon catheter.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon has a pinhole located at the proximal of the distal markerband, thereby confirming the reported event of balloon unable to inflate.Further examination was performed to the balloon material and markerbands and no damages were noted.A visual and tactile analysis were performed to the tip and the catheter shaft, and no damages or problems were found that could potentially have contributed to the reported event.It is possible that the interaction between the balloon and the kidney stone could have caused the found problem of balloon pinhole, resulting to the balloon inflation problem.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instruction 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 procedure performed on (b)(6) 2021.During the procedure, the balloon would not inflate.The procedure was completed with another uromax ultra dilation balloon catheter.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

• Brand Name: UROMAX ULTRA KIT
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13618399
• Report Number: 3005099803-2022-00877
• Device Sequence Number: 5731373
• Product Code: KOE
• UDI-Device Identifier: 08714729341284
• UDI-Public: 08714729341284
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: 05/16/2024
• Device Model Number: M0062251210
• Device Catalogue Number: 225-121
• Device Lot Number: 0027997364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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 Sex: Unknown