MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was about to be used in the right ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.During preparation, the end of the ureteral catheter was separated.The procedure was completed with another dual lumen ureteral 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.
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was about to be used in the right ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.During preparation, the end of the ureteral catheter was separated.The procedure was completed with another dual lumen ureteral 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
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h10: investigation results: the returned dual lumen ureteral catheter was analyzed, and a media analysis noted that the injection lumen (yellow) and guidewire lumen (green) were detached from the catheter and evidence was found after the analysis was performed.With all the available information, boston scientific could not conclude the reported break, but evidence was found that the lumen detached/separated.The most probable root cause traced to device design has been assigned to this investigation.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18305680
• Report Number: 2124215-2023-68391
• Device Sequence Number: 6783653
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K860337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Model Number: M0064051000
• Device Catalogue Number: 405-100
• Device Lot Number: 0031571642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female