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

Model Number	M0062251020
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon catheter was used in the ureterovesical junction (uvj) for a retrograde intrarenal surgery (rirs) procedure performed on (b)(6), 2022.During preparation, it was noted that the balloon broke when inflated to 20 atm within 10 seconds of the dilatation process.The procedure was completed with another uromax ultra balloon catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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 balloon catheter was used in the ureterovesical junction (uvj) for a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022.During preparation, it was noted that the balloon broke when inflated to 20 atm within 10 seconds of the dilatation process.The procedure was completed with another uromax ultra balloon catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h2: additional information: block d4 (lot number) and h4 (device manufacture date) block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result a visual examination of the returned complaint device revealed the balloon was torn longitudinally.No kinks or damage was found on the catheter of the device.The balloon was not folded which indicates that the device was subjected to positive pressure.An examination of the markerbands and the tip of the device identified no problems.It is possible that the device may have encountered difficult patient anatomy such as stenosis, calcification or tortuosity, which could have contributed to the longitudinal tear in the balloon.It should also be considered that based on the event description, that the device may have been inflated above the rated burst pressure of 20 atm causing the balloon to rupture.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.

• 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: 14291248
• Report Number: 3005099803-2022-02483
• Device Sequence Number: 14833963
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• UDI-Public: 08714729341123
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 03/24/2023
• Device Model Number: M0062251020
• Device Catalogue Number: 225-102
• Device Lot Number: 0025399219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/15/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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