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

Model Number	M0062251010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon was used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noted that the balloon would not inflate due to a leak.The procedure was completed with a different device.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.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8566327
• Report Number: 3005099803-2019-02216
• Device Sequence Number: 2511307
• Product Code: KOE
• UDI-Device Identifier: 08714729341116
• UDI-Public: 08714729341116
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 06/24/2021
• Device Model Number: M0062251010
• Device Catalogue Number: 225-101
• Device Lot Number: 0022297400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1