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

Model Number 230-100

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 334832117
• Report Number: 2124215-2024-06508
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White