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

Model Number	M0062251080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 dilatation balloon device was used in the left ureter during a ureteral stricture balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter was kinked.Additionally, it was also noted that catheter would not pass through the guidewire.The procedure was completed with another uromax ultra device.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 good.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of catheter kinked.Investigation result: a visual examination of the returned complaint device revealed that the balloon was folded and did not appear to have been subjected to positive pressure.A visual and tactile examination identified one kink on the shaft of the device.Functional analysis was performed; however, resistance was encountered due to the shaft kink.It is most likely that resistance was met during the procedure and excessive force was used when inserting the balloon, which is advised against in the dfu.The use of excessive force is consistent with the torn catheter.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 device was used in the left ureter during a ureteral stricture balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter was kinked.Additionally, it was also noted that catheter would not pass through the guidewire.The procedure was completed with another uromax ultra device.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 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: 8246924
• Report Number: 3005099803-2019-00079
• Device Sequence Number: 2125240
• Product Code: KOE
• UDI-Device Identifier: 08714729341185
• UDI-Public: 08714729341185
• 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): 02/12/2019

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: 03/30/2020
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0020471975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1
• Patient Age: 65 YR