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

Model Number	M0062251020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon was used in the kidney during a laser lithotripsy procedure performed on (b)(6) 2023.During preparation, when the physician opened the uromax kit, it was noted that the wire was broken.The procedure was completed with another uromax ultra balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code (b)(4) captures the reportable event of catheter break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h10: investigation result the returned uromax ultra balloon was analyzed, and a visual evaluation noted that the balloon was tightly folded which indicates that the balloon had not been inflated.The balloon is in good condition and no problems were identified to the balloon material.A visual and tactile analysis revealed that there were no problems found to the entire length of the shaft, markerband and the tip of the device.No problem with the device were noted.The reported event of catheter break was not confirmed.No problems were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Block h11: correction: block b5 (describe event or problem) and g1 (mfr site facility name) this supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon was used in the kidney during a laser lithotripsy procedure performed on (b)(6) 2023.During preparation, when the physician opened the uromax kit, it was noted that the wire was broken.The procedure was completed with another uromax ultra balloon.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 16501229
• Report Number: 3005099803-2023-01058
• Device Sequence Number: 16966767
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• UDI-Public: 08714729341123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 03/21/2025
• Device Model Number: M0062251020
• Device Catalogue Number: 225-102
• Device Lot Number: 0029090217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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