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

Model Number	M0062251170
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon dilation catheter device was used in the bladder and ureter during a left ureteroscopy with laser lithotripsy, cystoscopy with left ureteral stent removal, possible left ureteral stent placement and left retrograde pyelogram procedure performed on (b)(6) 2023.During the procedure, the physician noted an unexpected contrast in the ureter around balloon and the encore device no longer held pressure.The procedure was aborted without completing all the planned parts due to this event.It was reported that the balloon appeared intact during initial examination.The balloon was then re-examined, and it was identified that the balloon had a pinpoint hole when pressure was applied.A multi-length ureteral stent was placed for passive dilation, and the patient will have to return for another surgical procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g2: medwatch (b)(4).Block h6: imdrf device code a041001 captures the reportable event of pinhole.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17124189
• Report Number: 3005099803-2023-02987
• Device Sequence Number: 20445105
• Product Code: EZN
• UDI-Device Identifier: 08714729341253
• UDI-Public: 08714729341253
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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: 04/12/2025
• Device Model Number: M0062251170
• Device Catalogue Number: 225-117
• Device Lot Number: 0029219224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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