MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NOTTINGHAM ONE-STEP; DILATOR, CATHETER, URETERAL

Model Number	230-100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of serious injury and additional device required.Imdrf device code a0203 captures the reportable event of device broke.
Event or Problem Description
It was reported to boston scientific that a nottingham ureteral dilator was used during a procedure performed on (b)(6) 2023.During the procedure, the nottingham one step broke, and all pieces were retrieved.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of serious injury and additional device required.Imdrf device code a0203 captures the reportable event of device broke.Block h2: additional information.Block a1 (patient identifier), block a2 (age), block a3 (sex), block a4 (weight), block a6 (race), block b5 (describe event or problem), block e1 (initial reporter's name and phone number) and block h6 (impact code) have been updated based on the additional information received on february 07, 2024.
Event or Problem Description
It was reported to boston scientific that a nottingham ureteral dilator was used during a cystoscopy laser lithotripsy and ureteroscopy procedure performed on (b)(6)2023.During the procedure, the nottingham one step broke, and all pieces were retrieved by a grasper.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: NOTTINGHAM ONE-STEP
• Common Device Name: DILATOR, CATHETER, URETERAL
• 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: 18664657
• Report Number: 2124215-2024-06508
• Device Sequence Number: 8424289
• Product Code: EZN
• UDI-Device Identifier: 08714729192053
• UDI-Public: 08714729192053
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K851144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 230-100
• Device Catalogue Number: 230-100
• Device Lot Number: 0031778268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White