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

Model Number	M0066401081
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a amplatz super stiff was used to treat kidney stones during a ureteroscopy procedure in the ureter performed on (b)(6) 2024.During the procedure, it was noted that the guidewire was not advancing properly.The guidewire was removed, and it was noticed the polytetrafluoroethylene (ptfe) coating peeled off exposing the stainless-steel core, however it was still attached to the core wire.Another guidewire was attempted to be used, however, there was difficulty advancing the guidewire and found that it was buckled at the tip.The procedure was successfully completed with a sensor wire.The physician suspected urethral perforation of the patient after use of the first guidewire.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.

• 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: 18745398
• Report Number: 2124215-2024-09693
• Device Sequence Number: 6250432
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/21/2024

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: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0032853452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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: Other
• Patient Sex: Unknown