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

Model Number	M0062251170
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 device was used for a dilatation of the urinary passage procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noted that the shaft was slightly bent.The procedure was completed with another uromax ultra dilatation balloon catheter.There have been no patient complications 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 device was used for a dilatation of the urinary passage procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noted that the shaft was slightly bent.The procedure was completed with another uromax ultra dilatation balloon catheter.There have been no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Additional information: block d1, block d2 (pro code (product code), block d4 (model number, lot number, catalog number, expiration date and unique identifier (udi) #), block h4 and block h10.Block b3: date of event: date of event was approximated to (b)(6)2019 as no event date was reported.Block h6: problem code 2976 captures the reportable event of balloon catheter kinked.Block h10: 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.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6)/2019 as no event date was reported.Block h6: problem code 2976 captures the reportable event of balloon catheter kinked.Block h10: investigation result a visual examination of the complaint device revealed the shaft was kinked distal of the strain relief due to excessive force being applied to the delivery system.Visual and microscopic exmaination found no issue with the balloon material, tip, and markerbands of the device.It was also noted that the balloon had not been inflated.This failure is likely due to an interaction between the user and device, or sample, that caused or contributed to the error.It is likely that the failure may be due to inappropriate use of the device and incorrect sample preparation.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 catheter device was used for a dilatation of the urinary passage procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noted that the shaft was slightly bent.The procedure was completed with another uromax ultra dilatation balloon catheter.There have been no patient complications 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: 9586010
• Report Number: 3005099803-2019-06528
• Device Sequence Number: 3154488
• Product Code: EZN
• UDI-Device Identifier: 08714729302438
• UDI-Public: 08714729302438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/23/2020

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: 01/26/2020
• Device Model Number: M0062251170
• Device Catalogue Number: 225-117
• Device Lot Number: 0020209917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/20/2020; 02/24/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/07/2020; 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1