MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY UROMAX ULTRA¿; DILATOR, CATHETER, URETERAL

Model Number	M0062251280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
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 dilatation balloon device was used during a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that the catheter was kinked.The procedure was completed with another uromax ultra dilatation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation results; a visual examination of the returned complaint device found multiple kinks along the length of the device.The balloon was tightly folded, unused and the balloon protector was still in position over the balloon material.No issues were noted with the balloon material and the tip or markerbands of the device.The noted failure likely occurred due to handling/manipulation of the device during preparation that could have affected the device performance and its integrity; therefore, the most probable root cause is handling damage.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, there was no evidence that the device was used in a manner inconsistent with the labeled indications.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used during a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that the catheter was kinked.The procedure was completed with another uromax ultra dilatation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: UROMAX ULTRA¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7740308
• Report Number: 3005099803-2018-02472
• Device Sequence Number: 634362
• Product Code: EZN
• UDI-Device Identifier: 08714729341352
• UDI-Public: 08714729341352
• Combination Product (Y/N): N
• PMA/510(K) Number: K980795
• 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): 07/20/2018

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: 10/31/2020
• Device Model Number: M0062251280
• Device Catalogue Number: 225-128
• Device Lot Number: 21519722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1