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

Model Number	M0066401091
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0401 captures the reportable event of corewire break.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during a ureteroscopy procedure in the kidney on (b)(6) 2023.It was reported that nearing the end of the procedure, the amplatz wire broke.The procedure was completed with a sensor wire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0401 captures the reportable event of corewire break.Block h10: the returned amplatz super stiff was analyzed, and a visual evaluation noted that the coil wire was unraveled due to the corewire was detached at approximately 2.8 cm from distal tip to the transition point.Additionally, the core wire was kinked in the distal section.Therefore, the reported complaint was confirmed.Boston scientific has determined the most probable cause of this complaint is manufacturing deficiency.Since the problem found was traced to the design specification and an investigation to address this problem is in progress.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during a ureteroscopy procedure in the kidney on (b)(6) 2023.It was reported that nearing the end of the procedure, the amplatz wire broke.The procedure was completed with a sensor wire.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16781646
• Report Number: 3005099803-2023-02119
• Device Sequence Number: 6858496
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 05/23/2023

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: 07/05/2025
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 0029716441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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