MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401040
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ureteroscopy procedure, the physician tried to put the wire through the stent, it unraveled.The procedure was completed with another of the same device and there were no known patient complications reported.The analysis of the returned device identified core wire detachment.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable investigation results of core wire detached.The device was not returned for analysis; however, review of the media confirmed the reported problem of device unraveled material, as the distal tip was observed to be stretched, unraveled, and with the core wire detached.Based on this evidence, the observed device unraveled material was possibly to observe that the distal tip stretched, unraveled, and the core wire came detached, it may be related to some other factors such as; excessive manipulation of the device, the procedure during advancement maneuvers within the vessel and in the area of interest, the technique used by the physician and the normal procedural difficulties encountered during the procedure.Consequently, these difficulties, may have caused the device to collapse in a peeled and kink in the guidewire, therefore this problem affected the performance of the device and its integrity.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23720517
• Report Number: 2124215-2025-89246
• Device Sequence Number: 18246002
• Product Code: EZB
• UDI-Device Identifier: 08714729752660
• UDI-Public: (01)08714729752660(17)280805(10)37145479
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: M0066401040
• Device Catalogue Number: M0066401040
• Device Lot Number: 0037145479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 08/06/2025
• 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: Unknown