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

Model Number	M0062251200
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the lower urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2022.During preparation, the balloon ruptured when functional checking was performed.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the lower urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6), 2022.During preparation, the balloon ruptured when functional checking was performed.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0402 captures the reportable event of balloon ruptured.Block h10: investigation result the returned uromax ultra balloon device was analyzed, and a visual evaluation noted 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 inflation unit and the balloon was able to inflate to its rated burst pressure for 30 seconds without problem.The balloon was inflated and deflated three times repeatedly with no leaks or drop of pressure noted.No problems were identified to the balloon material.A visual and tactile analysis revealed that there were no problems found to the shaft, markerband and the tip of the device.No problems with the device were noted.The reported event of balloon bursting was not confirmed.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event (visual, physical and performance testing).Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 14274690
• Report Number: 3005099803-2022-02271
• Device Sequence Number: 5907698
• Product Code: KOE
• UDI-Device Identifier: 08714729341277
• UDI-Public: 08714729341277
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 07/18/2024
• Device Model Number: M0062251200
• Device Catalogue Number: 225-120
• Device Lot Number: 0028187213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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