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

Model Number	M0062251010
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an uromax balloon catheter was used in a procedure performed on an unknown date according to the complainant, the catheter of the device was found to have couple of kinks on it; hence, they decided not to use it on the patient.It is unknown how the procedure was completed.Attempts to obtain additional patient and procedure information have been unsuccessful.If further information is obtained, a supplemental mdr will be filed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the complaint device found multiple kinks along the length of the catheter shaft.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.
Event or Problem Description
It was reported to boston scientific corporation that a uromax balloon catheter was used in a procedure performed on an unknown date according to the complainant, the catheter of the device was found to have couple of kinks on it; hence, they decided not to use it on the patient.It is unknown how the procedure was completed.Attempts to obtain additional patient and procedure information have been unsuccessful.If further information is obtained, a supplemental mdr will be filed.No patient complications have been reported as a result of this event.

• Brand Name: UROMAX ULTRA¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6604077
• Report Number: 3005099803-2017-01692
• Device Sequence Number: 627757
• Product Code: EZN
• UDI-Device Identifier: 08714729341116
• UDI-Public: (01)08714729341116(17)20200206(10)20253415
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K980795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 02/06/2020
• Device Model Number: M0062251010
• Device Catalogue Number: 225-101
• Device Lot Number: 20253415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1