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

Model Number	M0062251070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.(b)(4).The device has not been received for analysis.Upon receipt and 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 ureter during a uteroscopy procedure performed on (b)(6) 2021.During preparation, the pressure was not reached and it was noted that the balloon has a leak.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the ureter in a procedure performed on (b)(6), 2021.During the procedure, the pressure was not reached and it was noted that the balloon has a leak.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) block h6: medical device code a0504 captures the reportable event of balloon leak.Block h10: investigation results a visual examination of the complaint device found 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 encore inflation unit and the balloon was inflated; however, the balloon was noted leaking due to a pinhole located distal from the proximal markerband, thereby confirming the reported event.A visual, tactile and microscopic analysis were performed to the balloon material, tip, markerbands and the catheter shaft, and no damages were found.It is possible that the device may have encountered difficult patient anatomy such as stenosis, calcification or tortuosity that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available this device was used per the directions for use (dfu) / product label.Block h11: correction: block d1, block d4 (model number, lot number, catalog number, expiration date, unique identifier (udi) #).Block g4 (premarket / 510(k)#) and block h4.

• 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: 12959697
• Report Number: 3005099803-2021-06257
• Device Sequence Number: 16592524
• Product Code: KOE
• UDI-Device Identifier: 08714729341345
• UDI-Public: 08714729341345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 04/26/2024
• Device Model Number: M0062251070
• Device Catalogue Number: 225-107
• Device Lot Number: 0027213281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 80 KG