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

Model Number	M0062251170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
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 dilatation balloon catheter was used in the left ureter during an endoscopic ureteral stricture balloon dilation procedure performed on (b)(6), 2019.According to the complainant, during the procedure, it was noted that the balloon burst when the pressure gradually increased.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 good.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation result: a visual examination of the complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Functional analysis was performed, when pressure was applied liquid was observed to be leaking from a balloon pinhole located at the distal markerband.An examination of the balloon material, distal markerband, tip of the device and shaft identified no issues.Based on the condition and evaluation of the returned device, the most probable root cause is cause traced to intentional off-label, unapproved, or contraindicated use since the problem was traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the labels.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.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the left ureter during an endoscopic ureteral stricture balloon dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst when the pressure gradually increased.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 good.

• 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: 9255997
• Report Number: 3005099803-2019-05239
• Device Sequence Number: 11400491
• Product Code: EZN
• UDI-Device Identifier: 08714729341253
• UDI-Public: 08714729341253
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 02/15/2018
• Device Model Number: M0062251170
• Device Catalogue Number: 225-117
• Device Lot Number: 0017703621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR