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

Model Number	M0064051000
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was used in the kidney during a urinary diversion procedure performed on (b)(6) 2022.During unpacking, it was noticed that the tip of the catheter lumen was bent and broken.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo submitted by the customer shows that the catheter was torn and bent at the tip.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16242518
• Report Number: 3005099803-2023-00121
• Device Sequence Number: 15053055
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 06/29/2025
• Device Model Number: M0064051000
• Device Catalogue Number: 405-100
• Device Lot Number: 0027589647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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: Male