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

Model Number	M0062251000
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 ureteral dilatation balloon was used in the right ureter during a ureteral stricture balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon breaks up during inflation.The procedure was completed with another uromax ultra ureteral dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the returned complaint device found that the a solidified inflation medium was noted within the balloon material which indicates that it had been subjected to positive pressure.Functional analysis found that liquid was leaking from a perforation in the shaft of the device.The shaft perforation was located distal to the strain relief and was approximately 5mm in length.The shaft was also noted to be damaged and stretched around the perforation.A visual and microscopic examination of the balloon material and markerband identified no tears or damage.The guidewire lumen was noted to be intact and undamaged.No issues were noted with the shaft of the device.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.There was no evidence to suggest that the device was used in a manner inconsistent with the labelled indications.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra ureteral dilatation balloon was used in the right ureter during a ureteral stricture balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon breaks up during inflation.The procedure was completed with another uromax ultra ureteral dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 ureteral dilatation balloon was used in the right ureter during a ureteral stricture balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon breaks up during inflation.The procedure was completed with another uromax ultra ureteral dilatation balloon.There were no patient complications reported as a result of this event.

• 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: 7951552
• Report Number: 3005099803-2018-60749
• Device Sequence Number: 19215231
• Product Code: EZN
• UDI-Device Identifier: 08714729341109
• UDI-Public: 08714729341109
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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: 03/14/2021
• Device Model Number: M0062251000
• Device Catalogue Number: 225-100
• Device Lot Number: 0021865580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 10/30/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/29/2018; 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR